BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VULCAN GENERATOR

    MDR report key: 1886334 · Received October 29, 2010

    Report

    Report Number
    1643264-2010-00015
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. PRODUCT PASSED FUNCTIONAL TESTING PER PROCESS SUMMARY 1202257 REV.H AND POWER CYCLE TESTS. PRODUCT DID NOT FAULT DURING 6 HOUR BURN-IN. NO PROBLEM FOUND. (B)(4).

    Description of Event or Problem · 1

    AFTER SHOULDER REPAIR PROCEDURE, DR NOTICED THAT THE PATIENT WAS BURNED ON THE RIGHT LEG. UNSURE HOW THE BURN TOOK PLACE BUT IT WAS AROUND THE EDGE OF THE GROUNDING PAD. THE BURNED AREA WAS SQUARE LIKE THE PAD AND DIDN'T KNOW IF IT WAS A BURN OR ADHESIVE REACTION. PATIENT FOLLOWED UP WITH PRIMARY CARE DOCTOR AND STAFF DOESN'T KNOW STATUS OF PATIENT. PAD WAS PLACED ON RIGHT THIGH WHICH IS CORRECT PLACEMENT FOR A SHOULDER CASE. CONMED PAD WAS USED FOR THE PROCEDURE INSTEAD OF RECOMMENDED VALLEY LAB PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN GENERATOR VULCAN GENERATOR, CE MARK GEI SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE 7210812S ZL1030

    Patients

    Seq Age Sex Outcome Treatment
    1