BEUDAMED
    FDA Adverse Event Summary report: N

    8360-10 AESCULAP PRESTIGE

    MDR report key: 3832312 · Received February 26, 2014

    Report

    Report Number
    1527590-2014-00001
    Date Received
    February 26, 2014
    Date of Event
    September 20, 2013
    Report Date
    February 26, 2014
    Product Code
    NWV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE REPORTED EVENT, THE UNIT WAS SENT TO SPECTRUM SURGICAL INSTRUMENTS FOR EVAL. AFTER ANALYZING COLOR OF THE METAL, SPECTRUM DETERMINED THAT THE FRACTURE WAS NOT IN EXISTENCE PRIOR TO THE INSTRUMENT'S FAILURE DURING SURGERY. IF A FRACTURE EXISTED FOR ANY PERIOD OF TIME, ONE WOULD EXPECT TO SEE HEAVY DISCOLORATION OR RUSTLING AROUND THE AREA OF THE FRACTURE. NO SUCH HEAVY DISCOLORATION OR RUSTLING APPEARS AT THE POINT OF FRACTURE. SPECTRUM'S EVAL OF THE LAPAROSCOPIC GRASPER DETERMINED THAT THE FRACTURE IN QUESTION WAS THE RESULT OF LARGE AMOUNTS OF PRESSURE APPLIED BY THE USER FACILITY DURING THE PROCEDURE. WHEN USING THE LAPAROSCOPIC GRASPER, THE USER IS CAUTIONED NOT TO APPLY LARGE AMOUNTS OF PRESSURE AND TO ALWAYS INSPECT THE INSTRUMENT BEFORE SURGERY TO ASSURE THEIR SUITABILITY FOR USE. IN (B)(4) OF 2013, APPROX ONE MONTH PRIOR TO THE REPORTED EVENT, SPECTRUM SURGICAL INSTRUMENTS REPAIRED THE UNIT IN QUESTION AS EVIDENCE BY THE DATE STAMP ETCHED ON THE INSTRUMENTS HANDLE. A NUMBER OF LIKE INSTRUMENTS WERE REPAIRED BY SPECTRUM DURING THE MONTH OF (B)(4). AS THIS INSTRUMENT DOES NOT CONTAIN A SERIAL NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE SPECIFIC REPAIR COMPLETED. HOWEVER, NO REPAIR THAT SPECTRUM PERFORMS WOULD IMPACT THE FRACTURED AREA OF THE GRASPER JAW. IF ANY DAMAGE TO THE GRASPER JAW IS SUSTAINED, THE PART IS NOT REPAIRED BUT RATHER REPLACED BY SPECTRUM. NO JAWS WERE REPLACED IN ANY OF THE REPAIRS ON THE LAPAROSCOPIC GRASPERS DURING THE MONTH OF (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PT PROCEDURE, THE LAPAROSCOPIC GRASPER FALL APART WHILE BEING USED INSIDE THE PT'S ABDOMEN. THE ABDOMEN WAS SEARCHED AND ALL PIECES WERE CONFIRMED TO HAVE BEEN RETRIEVED. NO INJURIES OR ADVERSE EFFECTS WERE REPORTED. A REPLACEMENT INSTRUMENT WAS SUPPLIED TO THE OPERATING ROOM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118003 8360-10 AESCULAP PRESTIGE AESCULAP PRESTIGE NWV

    Patients

    Seq Age Sex Outcome Treatment
    1