BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC PROTECTOR TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 1791648 · Received August 3, 2010

    Report

    Report Number
    1037905-2010-00352
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Report Date
    July 4, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A PHYSICIAN IN (B)(6). (B)(6). EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT ANY ELECTROSURGICAL ACCESSORY DEVICE CONSTITUTES A POTENTIAL ELECTRICAL HAZARD TO THE PT AND OPERATOR. FULGURATION AND BURNS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POSSIBLE ADVERSE EFFECTS. PRIOR TO DISTRIBUTION, ALL COOK ENDOSCOPY TRI-TOME PC PROTECTOR TRIPLE LUMEN SPHINCTEROTOME ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES VERIFICATION OF THE CONTINUITY BETWEEN THE CUTTING WIRE AND ELECTRICAL PIN. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SPHINCTEROTOMY THE PHYSICIAN SELECTED A TRI-TOME PC PROTECTOR TRIPLE LUMEN SPHINCTEROTOME. THE INSULATED PART OF THE CUTTING WIRE (60% OF THE CUTTING WIRE) SEEMS TO BE BURNING THE TISSUE WHEN IT TOUCHES CLOSE TO THE SPHINCTER OF ODDI. NO INTERVENTION WAS REQUIRED. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRI-TOME PC PROTECTOR TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)| OLYMPUS UES20 ELECTROSURGICAL GENERATOR| ACTIVE CORD (UNK TYPE)