BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO¿

    MDR report key: 6110042 · Received November 17, 2016

    Report

    Report Number
    3005099803-2016-03481
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FHQ
    UDI-DI
    08714729257615
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED CAPIO¿ REVEALED THAT THE DEVICE DOES NOT HAVE ANY VISUAL FAILURE NOR THE NEEDLE DETACHED. THE CARRIER WAS ACTUATED THREE TIMES AND IT EXTENDED AND RETRACTED WITHOUT ANY PROBLEM. HOWEVER, IT WAS ACTUATED (DEPLOYED) THREE TIMES WITH THE SUTURE AND THE NEEDLE WAS ABLE TO ENTER IN THE SLOT. ALSO AFTER THE FUNCTIONAL INSPECTION THE SUTURE WAS UNLOADED FORM THE DISTAL SECTION IN GOOD CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO" WAS USED DURING A VAGINAL/PARAVAGINAL DEFECT REPAIR PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO". THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO¿ WAS USED DURING A VAGINAL/PARAVAGINAL DEFECT REPAIR PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO¿. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759548 CAPIO¿ LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068311251 18134147 08714729257615

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other