BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2494456 · Received March 16, 2012

    Report

    Report Number
    1056128-2012-00026
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE RETURNED TO STRYKER SOLUTIONS (SSS) FOR AN EVALUATION. THIS MDR CORRESPONDS TO DEVICE WITH SERIAL NUMBER (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED AN INDENTION IN THE TEFLON PAD WHICH IS TYPICALLY CAUSED BY THE ACTIVATED BLADE CONTACTING THE PAD. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATE, "TAKE CARE TO AVOID APPLICATION OF PRESSURE BETWEEN THE BLADE AND TISSUE PAD WITHOUT TISSUE IN BETWEEN THEM AS THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT. THIS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED." THE DISTAL TIP OF THE BLADE WAS BROKEN OFF AND NOT RETURNED. A GOUGE WAS OBSERVED AT THE FRACTURE SITE. BASED ON THE DAMAGE OBSERVED, THE MOST LIKELY CAUSE FOR THE REPORT WAS DETERMINED TO BE AN IMPACT OF THE JAW WITH A SOLID SURFACE OR OBJECT. 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." 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 2 YEAR 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 PROCEDURE, THE ULTRASONIC SCALPEL STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1813145

    Patients

    Seq Age Sex Outcome Treatment
    1