BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS

    MDR report key: 6046711 · Received October 21, 2016

    Report

    Report Number
    6046711
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    June 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SITUATION: STRYKER SERFAS ENERGY 90-S 3.5 MM REF (B)(4) (LOT NO. 16127AE) METAL RING ON WAND BROKE OFF IN PATIENT'S RIGHT KNEE DURING USE. BACKGROUND: DR WAS IN PROGRESS WITH A RIGHT KNEE ARTHROSCOPY, LYSIS OF ADHESION, REMOVAL OF LOOSE BODY WITH ARTHROTOMY. ARTHROSCOPIC LATERAL RELEASE- A STRYKER SERFAS ENERGY 90-S 3.5 MM (LOT NO. 16127AE2) WAND WAS PROVIDED TO THE STERILE UPON REQUEST OF THE SURGEON. DURING USE- A TINY PORTION OF THE METAL RING OF THE WAND WAS QUICKLY IDENTIFIED IN THE PATIENT'S RIGHT KNEE BY THE SURGEON AND SURGICAL TEAM. ATTEMPTS WERE MADE BY THE SURGEON TO REMOVE THE FOREIGN BODY FROM THE RIGHT KNEE- FAILED TO RETRIEVE. ASSESSMENT: THE STRYKER WAND WAS IMMEDIATELY VISUALLY INSPECTED. AT THIS TIME IT WAS CONFIRMED THAT A PIECE OF THE METAL RING OF THE WAND WAS MISSING. THE MINI C-ARM WAS USED TO CONFIRM THE LOCATION OF THE FOREIGN BODY IN THE PATIENT'S RIGHT KNEE. THE STRYKER WAND WAS SAVED WITH PACKAGING CONTENT. ALL STRYKER SERFAS ENERGY 90-S 3.5 MM WITH LOT NO. 16127AE2 WERE REMOVED FROM CIRCULATION AND SHELVING FROM THE OPERATING ROOM. RECOMMENDATION: INFORM ALL PERIOPERATIVE SURGICAL HEALTH CARE SYSTEMS, IP, QPS, SUPPLY CHAIN OF THIS INCIDENT WITH RECOMMENDATIONS TO REMOVE THIS PRODUCT CONTAINING LOT NO. 16127AE2 UNTIL INVESTIGATION HAS BEEN COMPLETED. REPORT THIS INCIDENT TO STRYKER. FOLLOW UP ON PATIENT REQUIRED-ONGOING BY DR. RECOMMENDATION STATUS= ALL COMPLETED. DR WAS PERFORMING AN ARTHROSCOPIC KNEE SURGERY ON THIS PATIENT. ONE OF THE INSTRUMENTS USED WAS A SERFAS ENERGY 90-S (3.5MM) ELECTROSURGICAL PROBE. DR DESCRIBES THAT HE PASSED THE PROBE THROUGH SOME SOFT TISSUE AND WHEN HE RETRACTED IT, NOTICED THAT THE SMALL METAL PLATE WHICH FORMS THE ACTUAL CAUTERIZING SURFACE OF THE INSTRUMENT WAS MISSING. VISUAL INSPECTION OF THE KNEE JOINT FAILED TO REVEAL THE PLATE. FLUOROSCOPY WAS PERFORMED AND THE METAL PLATE IS VISIBLE, HOWEVER DUE TO ITS TINY SIZE AND APPARENT POSITION WITHIN SOFT TISSUE, DR. MADE THE DECISION TO SUSPEND THE SEARCH FOR THE PLATE. HE WAS CONCERNED FOR THE ADDITIONAL SURGICAL TIME, POSSIBLE TISSUE INJURY FROM CONTINUED EXPLORATION, AND THE VERY LOW CHANCE OF SUCH A TINY PIECE OF METAL LODGED IN SOFT TISSUE CAUSING ANY PROBLEMS IN THE FUTURE. MANUFACTURER RESPONSE FOR SERFAS ENERGY 90-S 3.5MM, (BRAND NOT PROVIDED) (PER SITE REPORTER): HAVE NOT YET HEARD BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700058 SERFAS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY 16127AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR