{ "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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(ISI); HOWEVER, THE CUSTOMER DID NOT SPECIFY WHICH INSTRUMENTS LEAD TO THE NEED FOR THE SITE TO PERFORM X-RAYS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT IS UNKNOWN, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "357977736", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED UNSPECIFIED INSTRUMENTS THAT HAVE DEVELOPED BROKEN CABLES, RESULTING IN X-RAYING OF PATIENTS TO CONFIRM NO FRAGMENTS WERE LEFT BEHIND. REPORTEDLY THE SUSPECTED INSTRUMENTS HAVE ALREADY BEEN RETURNED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: NOT ALL CASES INVOLVING A BROKEN INSTRUMENT HAVE AN X-RAY PERFORMED AS A RESULT; THAT DECISION IS MADE BY THE SURGEON. 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