{ "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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STAPLER CLAMPED DOWN ON TISSUE AND WAS NOT ABLE TO DISCONNECT. SURGEON PRESSED EMERGENCY RELEASE BUTTON ON CONSOLE AND ASSIST USED EMERGENCY SCREW TO UNLOCK STAPLER FROM PATIENT WITH NO SUCCESS. DAVINCI REP CALLED AND CAME IN TO ASSIST. SURGEON WAS ABLE TO REMOVE STAPLER AND PROCEED WITH SURGERY. INSTRUMENT MALFUNCTION. WORKING WITH INTUIT REMOTELY, VENDOR WAS ABLE TO WORK WITH PHYSICIAN TO SUCCESSFULLY DISENGAGE STAPLER FROM BOWEL. INSTRUMENT WAS LABELLED AND REMOVED FROM SERVICE. VENDOR HAS SUBMITTED REQUEST FOR IR. A (B)(6) YEAR OLD MALE WITH QUADRIPLEGIA SUSTAINED AFTER DIVING INTO 3 FT OF WATER. HE UNDERWENT C4-5/6 ACDF WITH PLATING ON (B)(6) 2021. HE WAS INTUBATED FOR RESPIRATORY DISTRESS AND HAD TRACH PLACED (B)(6) 2021. PEG PLACED ON (B)(6) 2021. HIS HOSPITAL COURSE WAS COMPLICATED BY BRADYCARDIA WITH ASYSTOLE, NEUROGENIC SHOCK AND MUCUS PLUGGING. LAST COLONOSCOPY ~ 3 YEARS AGO, HE DOES HAVE A HISTORY OF COLON POLYPS, NO KNOWN FAMILY HISTORY OF COLON CANCER. HISTORY OF UMBILICAL HERNIA REPAIR WITH MESH MANY YEARS AGO. HE IS NOW AT A FACILITY FOR REHABILITATION. WE HAVE BEEN CONSULTED FOR COLOSTOMY TO HELP EASE CARE. HE WISHES TO HAVE SPT PLACED AS A COMBINED PROCEDURE WITH UROLOGY. NKDA TOBACCO USE - (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }