BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANDLE CEV10195R DIA 5MM ANG W/ RATCHET

    MDR report key: 2556992 · Received May 2, 2012

    Report

    Report Number
    9680837-2012-00015
    Event Type
    Death
    Date Received
    May 2, 2012
    Date of Event
    June 3, 2011
    Report Date
    April 5, 2012
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE RETURNED INSTRUMENTS ARE AS FOLLOWS: ALTHOUGH SOME DEFECTS ON THE INSTRUMENTS RETURNED (DUE TO SOME EXCESSIVE USE BY THE CUSTOMER / REPAIR BY A NON-CONTRACTED THIRD PARTY) HAVE BEEN DETECTED, IT IS UNLIKELY THAT THEY COULD BE THE PRIMARY CAUSE OF THE INCIDENT DESCRIBED. NO ELECTRICAL MALFUNCTIONS OR EVIDENCES OF IT WERE HIGHLIGHTED DURING THE INVESTIGATION. FOR YOUR INFORMATION, AMONG ALL LAPAROSCOPY BOX RETURN (41 INSTRUMENTS), ONLY 13 PRODUCTS WERE MANUFACTURED BY MXI. THE FOLLOWING INSTRUMENTATION WAS REPORTED DURING THE ANALYSIS THAT WERE NOT REPORTED BY THE INITIAL REPORTER, THEREFORE, THE FOLLOWING ARE BEING SUBMITTED AS CONCOMITANT: (B)(4) 5B DIA 5MM 350MM, QUANTITY - 3 HANDLE (B)(4) DIA 5MM, ANG W/ RATCHET - QTY - 2 INSERT (B)(4) FENESTRATED, 350MM, QTY - 2 SCISSORS INSERT (B)(4) 3PK, 350MM. QTY - 1 INSERT (B)(4) GRASPING DIA, 5MM 350MM, QTY - 1 UPDATED: CONCLUSION - USE ERROR CAUSED OR CONTRIBUTED TO EVENT (B)(4); DEVICE-DEVICE MAINTENANCE ISSUE (B)(4); RESULTS-FDR-MAINTENANCE PROBLEM (B)(4); METHOD-ACTUAL DEVICE EVALUATED (B)(4); IMAGE INSPECTION (B)(4); PHOTOGRAPHIC INSPECTION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. 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. REPORT INCONCLUSIVE. 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. DEVICE INFORMATION: LAPAROSCOPIC INSTRUMENTS ARE WELL-SUITED FOR PERFORMING A VARIETY OF LAPAROSCOPIC PROCEDURES, INCLUDING CHOLECYSTECTOMY, APPENDECTOMY, HERNIA REPAIR, COLORECTAL SURGERY, AND BARIATRIC SURGERY. EACH MODULAR LAPAROSCOPIC INSTRUMENT IS COMPOSED OF THREE COMPONENTS: A HANDLE, TUBE, AND JAW TIP. MANY DIFFERENT HANDLES ARE AVAILABLE AS BIPOLAR, AXIAL, ERGONOMIC, AND ANGLED HANDLES MAY BE AVAILABLE EITHER ROTATABLE OR NON-ROTATABLE. MANUAL SURGICAL INSTRUMENTS ARE INTENDED FOR USE IN A WIDE VARIETY OF SURGICAL PROCEDURES INCLUDING OTORHINOLARYNGOLOGY, HEAD AND NECK, OTONEUROLOGICAL, OPHTHALMIC, AND VARIOUS LAPAROSCOPIC AND ENDOSCOPIC SURGERIES. THE INSTRUMENTS ARE INTENDED TO SCRAPE, CUT, GRASP, HOLD, REMOVE, OR MANIPULATE TISSUE OR STRUCTURES. THEY INCLUDE INSTRUMENT TRAYS AND SUCTION DEVICES DESIGNED TO EVACUATE GAS, FLUID, TISSUE OR OTHER FOREIGN MATERIALS. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO SELECT THE APPROPRIATE INSTRUMENT FOR EACH CASE. THE INSTRUMENTS CAN CONSIST OF ANY OF THE FOLLOWING PATIENT CONTACTING MATERIALS: (B)(4). CHECK THE CONDITION OF INSTRUMENTS BEFORE AND AFTER EACH CASE. REMOVE FROM USE ANY INCOMPLETE OR POORLY OPERATING INSTRUMENTS. DO NOT BEND, PRY, OR USE EXCESSIVE FORCE, BREAKAGE OR FAILURE OF THE INSTRUMENT COULD OCCUR RESULTING IN POSSIBLE HARM TO THE PATIENT OR USER. INSPECT COMPONENTS FOR ANY DAMAGE BEFORE AND AFTER EACH USE. IF DAMAGE IS OBSERVED DO NOT USE THE INSTRUMENT UNTIL IT IS REPAIRED. AFTER CLEANING AND STERILIZATION, VERIFY FUNCTIONALITY PRIOR TO RE-USE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT (B)(4), LOT # 200905MF4.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE THE PATIENT'S COLON WAS PERFORATED ALLEGEDLY DUE TO AN ELECTRICAL BURN WHICH LED TO THE PATIENT'S DEATH. THE LAPAROSCOPY SET USED DURING THIS SURGICAL CASE WAS CONTAINED AMONG OTHERS; 3 MONOPOLAR LAPAROSCOPY HANDLES AND 1 BIPOLAR LAPAROSCOPY HANDLE FROM THIS MANUFACTURER. IT IS NOT CLEAR IF THIS MANUFACTURER'S INSTRUMENTS WERE USED, BUT THE SET WAS PRESENT. IT WAS REPORTED THAT "IT IS POSSIBLE THAT THIS INCIDENT WAS DUE TO THE SURGERY ACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE CEV10195R DIA 5MM ANG W/ RATCHET ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV10195R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death