LOT # 201011MF3. (B)(4). (B)(4) 2012 -THE MANUFACTURER'S DEVICE ANALYSIS RESULTS. THE TROCAR SLEEVE (B)(4), LOT 201011MF3 WAS RETURNED TO MEDTRONIC FOR ANALYSIS. SAMPLE WAS FOUND TO BE BROKEN ON THE UPPER PART OF THE INSTRUMENT. BY LOOKING IN DETAILS AT THE BREAKAGE AREA, THE CUT IS CLEAN WITHOUT MISSING PIECES. THE REMAINING PIECES OF THE INSTRUMENTS SEEMS TO HAVE CONSERVED THEIR RIGIDNESS PROPERTIES (RESISTANCE TO CONSTRAINT) AND DOES NOT APPEAR BRITTLE. MULTIPLES EVIDENCES OF ABRASION/DAMAGES WAS NOTED AT THE EXTREMITY OF THE SLEEVE. THE RETURNED SLEEVE WAS MORE THAN 1 YEAR OLD. (MANUFACTURED ON OCTOBER 2010) CONSIDERING THE OBSERVATIONS OF SAMPLES RETURNED AND OBSERVED: MARKS AND SCRATCHES ON ALL SLEEVES. AGE OF ALL RETURNED DEVICES (MORE THAN 1 YEAR OLD). OBSERVED STIFFNESS OF THE RETURNED SLEEVES. WE CAN REASONABLY SUSPECT THAT THE OBSERVED BREAKAGES OF TROCAR ARE THE CONSEQUENCE OF ABNORMAL CONSTRAINTS APPLIED REGULARLY AND THROUGH A LONG PERIOD OF TIME AND THAT CRACKS AND MARKS SHOULD HAVE BEEN NOTICED PRIOR USE AS SUGGESTED BY OUR IFU'S.
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Patient 1
IT WAS REPORTED THAT DURING A SCHEDULED LAPAROSCOPIC UROLOGY PROCEDURE, A TROCAR WAS BROKEN IN THE ABDOMEN OF THE PATIENT WHEN THE DOCTOR REMOVED IT. ALL PIECES WERE REMOVED AND NO PARTS WERE LEFT INTO THE PATIENT. THE WAS NO REPORTED IMPACT TO THE PATIENT.
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Patient 1
(B)(4). MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER THE DEVICE IN QUESTION, APPLICABLE IMAGING FILMS, NOR MEDICAL RECORDS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED PRODUCT PROBLEM AND ADVERSE EVENT. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED SINCE INITIAL DISTRIBUTION. A TROCAR CONSISTS OF A BLADELESS OBTURATOR AND HOUSING/TROCAR SLEEVE. IT CONTAINS A SEALING SYSTEM TO MAINTAIN INSUFFLATION WHEN INSTRUMENTS ARE INSERTED OR WITHDRAWN. INSIDE THE NEEDLE CANNULA AND EXTENDING BEYOND THE NEEDLE TIP, IS A SPRING-LOADED BLUNT STYLET MECHANISM. THE STYLET RETRACTS AS A ACCESS NEEDLE IS PUSHED THROUGH THE ABDOMINAL TISSUE AND AUTOMATICALLY ADVANCES FORWARD ONCE THE ABDOMINAL CAVITY HAS BEEN ENTERED. THE OUTER SLEEVE CONTAINS AN INTERNAL GASKET TO MINIMIZE GAS LEAKAGE WHEN INSTRUMENTS ARE INSERTED AND WITHDRAWN.