BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1850383 · Received October 1, 2010

    Report

    Report Number
    3005099803-2010-03949
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 28, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. (B)(4) THE REPORTED EVENT OF NEEDLE DETACHMENT - UNKNOWN LOCATION OF DETACHED NEEDLE.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH NO OBVIOUS ANOMALIES. MECHANICAL TESTS PERFORMED ON THE DEVICE FOUND THAT IT WAS ABLE TO LOAD, FIRE AND CATCH A SAMPLE SUTURE ALL THREE TIMES IT WAS ACTUATED. NO PIECES OF THE REPORTED DETACHED SUTURE WERE RECEIVED OR FOUND INSIDE THE RETURNED DEVICE. PER THE DFU, "ONLY NEEDLES AND SUTURES SPECIFIED FOR USE WITH THE CAPIO SUTURE CAPTURING DEVICE" ARE TO BE USED. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS USER/USE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL HYSTERECTOMY WITH SLING PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NEEDLE ATTACHED TO AN ETHICON SUTURE (MANUFACTURED BY ETHICON INC.) DETACHED WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT A SLING INTO THE PATIENT (SLING TYPE AND MANUFACTURER UNKNOWN). THE PHYSICIAN WAS REPORTEDLY UNABLE TO LOCATE THE DETACHED NEEDLE; HENCE IT IS UNKNOWN IF THE NEEDLE DETACHED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL HYSTERECTOMY WITH SLING PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NEEDLE ATTACHED TO AN ETHICON SUTURE (MANUFACTURED BY ETHICON INC.) DETACHED WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT A SLING INTO THE PATIENT (SLING TYPE AND MANUFACTURER UNKNOWN). THE PHYSICIAN WAS REPORTEDLY UNABLE TO LOCATE THE DETACHED NEEDLE; HENCE IT IS UNKNOWN IF THE NEEDLE DETACHED INSIDE OR OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    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 13026312

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ETHICON SUTURE (MANUFACTURER: ETHICON INC.)| SLING (TYPE AND MANUFACTURER UNKNOWN)