BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2840726 · Received November 20, 2012

    Report

    Report Number
    1056128-2012-00136
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP OF THE SCALPEL BLADE WAS BROKEN OFF. MICROSCOPIC INSPECTION OF THE SCALPEL BLADE REVEALED A GOUGE ON EACH SIDE OF THE FRACTURE. ADDITIONALLY, THE JAW (PAD/ARM SUBASSEMBLY) OF THE DEVICE WAS OBSERVED TO BE PARTIALLY DETACHED. THE JAW WAS HINGED TO THE EXTERNAL SHAFT BUT UNHINGED FROM THE ACTUATING SHAFT. THE ACTUATING SHAFT WAS BENT AND THE HINGE SOCKETS WERE TORN. THERE WAS ALSO AN INDENTION IN THE TEFLON PAD. THE OBSERVED PAD INDENTION IS TYPICALLY CAUSED BY CLOSING THE JAW WITHOUT TISSUE BETWEEN THE ACTIVATED BLADE AND PAD, WHICH SUGGESTS THE JAW WAS INITIALLY INTACT DURING CLINICAL USE. BASED ON THE DAMAGE OBSERVED, THE MOST LIKELY CAUSE FOR THE REPORT WAS DETERMINED TO BE AN IMPACT OF THE JAW WITH A HARD OBJECT SUCH AS A STAPLE OR SURGICAL CLIP DURING CLINICAL USE. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATE: "AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS DURING INSTRUMENT ACTIVATION. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS DURING INSTRUMENT ACTIVATION MAY RESULT IN PREMATURE BLADE FAILURE, RESULTING IN GENERATOR SOLID TONE OR INSTRUMENT ERROR." "INTRODUCING OR WITHDRAWING THE INSTRUMENT WITH THE JAWS OPEN THROUGH A TROCAR SLEEVE MAY DAMAGE THE INSTRUMENT." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A (B)(4) REPORTING CYCLE DUE TO MDR REPORT 1056128-2011-00021 WHERE THE TIP OF THE DEVICE REMAINED IN THE PATIENT EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE "THE TIP BROKE" OFF OF THE ULTRASONIC SCALPEL. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 2138063

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR