BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT MAXX BIOPSY FORCEPS WITHOUT SPIKE

    MDR report key: 2210169 · Received August 4, 2011

    Report

    Report Number
    1037905-2011-00508
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KGE
    PMA / PMN Number
    K000086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS RETURNED TO THE APPROVED FORCEPS SUPPLIER FOR EVAL. THE INFO PROVIDED BY THE SUPPLIER CONFIRMED THE REPORT AS DESCRIBED. A SMALL SPLIT IN THE COATING WAS IDENTIFIED DISTAL TO THE STRAIN RELIEF SECTION OF THE HANDLE. IN ADDITION A TORN AREA IN THE OUTER COATING WAS NOTICED 51 INCHES FROM THE STRAIN RELIEF SECTION OF THE HANDLE. THE COATING IS JAGGED AND APPEARS TORN AT THESE DAMAGED AREAS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: WE CAN REPORT THAT EXCESSIVE TIME AND TEMPERATURE DURING AUTOCLAVE STERILIZATION CAN CAUSE DAMAGE TO THE OUTER SHEATH, SUCH AS A HOLE OR SPLIT. THE INSTRUCTIONS FOR USE SPECIFY THE AUTOCLAVE PARAMETERS AS 270 DEGREES FAHRENHEIT FOR 5 MINUTES. THIS DEVICE IS NOT RECOMMENDED FOR USE WITH GAS STERILIZATION. THE ADD'L INFO PROVIDED INDICATED THE DEVICE IS CLEANED AND STERILIZED PER THE INSTRUCTIONS FOR USE GUIDELINES. PRIOR TO DISTRIBUTION, ALL HOT MAXX FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE OUTER SHEATH OF THE COOK REUSABLE HOT MAXX BIOPSY FORCEPS WITHOUT SPIKE BECOMES DAMAGED OVER TIME. THIS IS A REUSABLE DEVICE THAT HAD BEEN USED LESS THAN 10 TIMES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT MAXX BIOPSY FORCEPS WITHOUT SPIKE KGE, FORCEPS, BIOPSY, ELECTRIC KGE WILSON-COOK MEDICAL, INC. W2967886

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL POWER SUPPLY (UNK TYPE)| OLYMPUS UPPER ENDOSCOPE (UNK TYPE),| ACTIVE CORD (UNK TYPE)