BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1931651 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05273
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION 'DESCRIBE EVENT OR PROBLEM' WAS UPDATED WITH ADDITIONAL INFORMATION RECEIVED. WHILE THE EXACT WEIGHT OF THE PATIENT IS UNAVAILABLE, IT WAS REPORTED THAT THE PATIENT WAS NOT "MORBIDLY OBESE." A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE UNIT WAS NOT RETURNED BY THE CUSTOMER; NO PRODUCT ANALYSIS COULD BE PERFORMED, AND THEREFORE THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. HOWEVER, IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE FIRST THROW OF THE DEVICE, THE CAPIO CAGE WOULD NOT CATCH THE NEEDLE. REPORTEDLY, NEITHER THE CAPIO CAGE NOR THE CAPIO CARRIER APPEARED TO BE DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL PROLAPSE REPAIR PROCEDURE PERFORMED WITH A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE CAPIO DEVICE WAS PLACED IN THE PATIENT AND THE PLUNGER WAS DEPRESSED. UPON REMOVAL OF THE CAPIO DEVICE FROM THE PATIENT, IT WAS FOUND THAT "THE NEEDLE AND SUTURE WERE NOT ATTACHED TO THE CAPIO AS EXPECTED." ACCORDING TO THE COMPLAINANT, INSPECTION OF THE CAPIO DEVICE SHOWED THAT THE PLUNGER WOULD NOT RETRACT AND THE PLUNGER "FELT STIFF." PER THE PHYSICIAN, THE PLUNGER COULD ONLY BE RETRACTED MANUALLY. THE CAPIO DEVICE REPORTEDLY EXHIBITED NO VISUAL ABNORMALITIES. REPORTEDLY, THE CAPIO WAS CLEANED TO REMOVE ANY DEBRIS THAT COULD BE INTERFERING WITH THE MECHANISM, BUT THIS DID NOT RESOLVE THE PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE "WITHOUT INCIDENT" AND WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS IN "GOOD" CONDITION POST-PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 13848650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR SUTURE (TYPE UNKNOWN)