{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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AN APPROXIMATELY 3MM PIECE OF THE MONOPOLAR CURVED SHEARS JAW TIP CHIPPED OFF AND FELL INTO THE PATIENT. THE PIECE FELL IN THE VICINITY OF THE DORSAL ASPECT OF THE SMALL INTESTINE IN THE RIGHT LOWER ABDOMEN. ADDITIONAL TASKS DURING THE PROCEDURE WERE PERFORMED, INCLUDING MOBILIZATION OF THE INTESTINAL TRACT TO SEARCH FOR FRAGMENTS AND FURTHER LAPAROSCOPIC MANIPULATIONS. THE LOCATION OF THE DISENGAGED PIECE WAS IDENTIFIED VIA INTRAOPERATIVE X-RAY, WHILE BEING MONITORED IN REAL TIME, AND ULTIMATELY RETRIEVED USING A SUCTION TUBE. THE PROCEDURE WAS EXTENDED BY FORTY-FIVE MINUTES DUE TO THE ISSUE. ADDITIONAL SURGERY WILL NOT BE REQUIRED." }, { "mdr_text_key": "402923332", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3) PRELIMINARY DEVICE EVALUATION: MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED MONOPOLAR CURVED SHEARS. EVALUATION OF THE ASSOCIATED DEVICE LOGS NOTED NO ERRORS ASSOCIATED WITH THE MONOPOLAR CURVED SHEARS. THE TOTAL USE TIME WAS NINETY-SIX MINUTES WITH A USE COUNT OF ONE, WHILE ATTACHED TO ARM CART ASSEMBLY 4. THREE IMAGES WERE RECEIVED FOR EVALUATION. ONE IMAGE DEPICTED AN X-RAY SCREEN WHERE A MONOPOLAR CURVED SHEARS HAD A BROKEN JAW PIECE. ONE IMAGE DEPICTED THE BROKEN JAW PIECE ALONG SIDE THE MONOPOLAR CURVED SHEARS. ONE IMAGE DEPICTED A MONOPOLAR CURVED SHEARS WITH A BROKEN JAW. FURTHER EVALUATION OF THE REPORTED MONOPOLAR CURVED SHEARS IS STILL PENDING, AND THE INVESTIGATION IS NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REGULATORY REPORT WHEN THE INVESTIGATION IS COMPLETE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "16340148055", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D9: DEVICE AVAILABLE FOR EVALUATION?, RETURN DATE, H3 AND H6: ANNEX B AND ANNEX D HAVE BEEN UPDATED. DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE RETURNED MONOPOLAR CURVED SHEARS (MCS), AS WELL AS THE ASSOCIATED DEVICE DATA AND PROVIDED IMAGES. VISUAL INSPECTION OF THE RETURNED MCS NOTED NO CORROSION ON THE ELECTRICAL CONTACTS. ONE OF THE JAWS OF THE INSTRUMENT WAS BROKEN. THE DISENGAGED PIECE WAS RETURNED. MICROSCOPIC INSPECTION OF THE DRIVE CABLES NOTED NO DAMAGE. FUNCTIONALLY, THE JAWS WERE MANIPULATED THROUGH THEIR FULL RANGE OF MOTION TO INSPECT THE CABLES. THE JAWS WERE ABLE TO ACHIEVE FULL ARTICULATION WITHOUT DIFFICULTY. ELECTRICAL TESTING WAS PERFORMED AND THE INSTRUMENT WAS READ WITH NO OBSERVED FAILURES. EVALUATION OF THE DEVICE DATA INDICATES NO ERRORS OCCURRED WITH THE REPORTED MCS. THE LOGS DO NOT TRACK THE PHYSICAL CONDITION OF THE INSTRUMENT. THE MCS HAD A TOTAL USE TIME OF NINETY-SIX MINUTES AND A USE COUNT OF ONE. REVIEW OF THE PROVIDED IMAGES NOTES THREE IMAGES WERE PROVIDED. THE FIRST IMAGE SHOWS PERSONNEL POINTING AT THE BROKEN PIECE OF THE MCS JAW ON A REAL TIME X-RAY SCREEN. THE SECOND IMAGE SHOWS THE DAMAGED MCS WITH THE BROKEN PIECE OF JAW BESIDE IT. THE THIRD IMAGE SHOWS THE DAMAGED MCS WITH ONE OF THE JAWS BROKEN, HOWEVER THE BROKEN JAW IS NOT SEEN IN THE IMAGE. EVALUATION OF THE MONOPOLAR CURVED SHEARS CONFIRMED THE REPORTED CONDITION, HOWEVER, THE INVESTIGATION CONCLUDED THERE WERE NO ABNOR MALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION; THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE OF THE OBSERVED JAW DAMAGE CAN OCCUR IF THE DEVICE WAS NOT USED AS INTENDED. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO ADDRESS THIS ISSUE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "15840148054", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING THE RESECTION AND INCISION OF SURROUNDING TISSUE, SUCH AS THE BLADDER AND URETHRA, FOR A ROBOT-ASSISTED LAPAROSCOPIC PROSTATE RESECTION PROCEDURE, ONE INSTRUMENT WAS BEING USED TO REMOVE CHARRED RESIDUE FROM ANOTHER INSTRUMENT AND A COLLISION OCCURRED. AN APPROXIMATELY 3MM PIECE OF THE MONOPOLAR CURVED SHEARS JAW TIP CHIPPED OFF AND FELL INTO THE PATIENT. THE PIECE FELL IN THE VICINITY OF THE DORSAL ASPECT OF THE SMALL INTESTINE IN THE RIGHT LOWER ABDOMEN. ADDITIONAL TASKS DURING THE PROCEDURE WERE PERFORMED, INCLUDING MOBILIZATION OF THE INTESTINAL TRACT TO SEARCH FOR FRAGMENTS AND FURTHER LAPAROSCOPIC MANIPULATIONS. THE LOCATION OF THE DISENGAGED PIECE WAS IDENTIFIED VIA INTRAOPERATIVE X-RAY, WHILE BEING MONITORED IN REAL TIME, AND ULTIMATELY RETRIEVED USING A SUCTION TUBE. THE PROCEDURE WAS EXTENDED BY FORTY-FIVE MINUTES DUE TO THE ISSUE. ADDITIONAL SURGERY WILL NOT BE REQUIRED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "60 MIDDLETOWN AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112-4391", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/08/2026" } ] }