BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA SUTURE PASSER, CAPTURE

    MDR report key: 17740849 · Received September 13, 2023

    Report

    Report Number
    0002936485-2023-00928
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 13, 2023
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    UDI-DI
    07613327413595
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: EIB, (B)(6), SPORTS MED ASR, NEEDLE BENT, SAMPLE. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE: 1) USE OF EXCESSIVE FORCE, 2) ATTEMPT TO PASS THROUGH THICK TISSUE OR BONE, 3) EXCESSIVE TISSUE LOADED INTO JAWS, 4) ATTEMPT TO LOAD OR PASS INCOMPATIBLE SUTURE, 5) TECHNIQUE ERROR. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE BECAME BENT WHILE THE DEVICE WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747811 COBRA SUTURE PASSER, CAPTURE ACCESSORIES, ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE 07613327413595

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown