BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 3182963 · Received June 21, 2013

    Report

    Report Number
    0002936485-2013-00267
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. PROBABLE ROOT CAUSES FOR THE REPORTED FAILURE MODE COULD BE: DESIGN, USER PREFERENCE AND/OR STYLE. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    DUE TO SYSTEM UPDATES, THE PART NUMBER INVOLVED IN THIS EVENT COULD NOT BE AUTO POPULATED AND IS BEING PROVIDED BELOW:PART NUMBER AND DESCRIPTION: 310-034-114 SQUARE PUNCH, 9 DEGREE, UPSHAFT. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT KNEE SCOPE, THE SURGEON FOUND THAT THE ERGONOMICS OF THE UNIT WERE NOT GOOD FOR SINGLE-PORTAL ARTHROSCOPY. A SHARP RIDGE ON THE HINGE OF THE UNIT WAS FOUND TO HAVE SOFT TISSUE ON THE BACK OF THE JAW. THIS REPRESENTS ARTICULAR CARTILAGE THAT HAS BEEN SCRAPED BY THE UNIT. FURTHERMORE, YOU CAN SEE THE CONDYLE HAD BEEN SUPERFICIALLY SCRAPED. THE DOCTOR CONFIRMED THAT THE DAMAGE TO THE ARTICULAR CARTILAGE IS SUPERFICIAL AND MINOR, THE DOCTOR ALSO CONFIRMED THAT THE DEFECTS CAUSED WERE NORMAL FOR ARTHROSCOPY SURGERY AND IT WILL NOT AFFECT THE PATIENT OUTCOME IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT KNEE SCOPE, THE SURGEON FOUND THAT THE ERGONOMICS OF THE UNIT WERE NOT GOOD FOR SINGLE-PORTAL ARTHROSCOPY. A SHARP RIDGE ON THE HINGE OF THE UNIT WAS FOUND TO HAVE SOFT TISSUE ON THE BACK OF THE JAW. THIS REPRESENTS ARTICULAR CARTILAGE THAT HAS BEEN SCRAPED BY THE UNIT. FURTHERMORE, YOU CAN SEE THE CONDYLE HAD BEEN SUPERFICIALLY SCRAPED. THE DOCTOR CONFIRMED THAT THE DAMAGE TO THE ARTICULAR CARTILAGE IS SUPERFICIAL AND MINOR, THE DOCTOR ALSO CONFIRMED THAT THE DEFECTS CAUSED WERE NORMAL FOR ARTHROSCOPY SURGERY AND IT WILL NOT AFFECT THE PATIENT OUTCOME IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283116 UNKNOWN_ENDOSCOPY_PRODUCT ACCESSORIES,ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1