BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND SWITCH FOR ELECTRIC PEN DRIVE

    MDR report key: 3192603 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04138
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO: DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE MDR REPORT ABILITY STATUS UPDATED TO: DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT: #8030965-2013-04138. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A PODIATRY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2013, THE ELECTRIC PEN DRIVE HAD NO POWER. THE ELECTRIC PEN DRIVE WAS BEING USED IN COMBINATION WITH THE HAND SWITCH AND A 4M CABLE. THE ELECTRIC PEN DRIVE AND HAND SWITCH WERE SWAPPED OUT WITH THE SAME TYPE OF PRODUCT BUT STILL HAD NO POWER. THERE WAS NO SPARE CABLE AVAILABLE TO SWAP WITH. A SPARE SYSTEM, DIFFERENT FROM THE ELECTRIC PEN DRIVE, WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO THE PATIENT. IT IS REPORTED PROCEDURE WAS DELAYED APPROXIMATELY 10 MINUTES. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292470 HAND SWITCH FOR ELECTRIC PEN DRIVE HWE SYNTHES GMBH AV16078

    Patients

    Seq Age Sex Outcome Treatment
    1