BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB

    MDR report key: 21323683 · Received February 6, 2025

    Report

    Report Number
    1216677-2025-00008
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 18, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GDW
    UDI-DI
    00867516000104
    PMA / PMN Number
    K120373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCTS WERE MANUFACTURED AT CSI ON 9/27/2024. MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED, AND NO NONCONFORMITIES RELATED TO THE COMPLAINT CONDITION WERE NOTED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS, HOWEVER, IN THOSE CASES NO PRODUCT WAS RETURNED FOR INVESTIGATION, SO THE COMPLAINTS WERE NOT CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN. HOWEVER, (B)(4). CLOSED BOXES AND (B)(4).UNUSED INDIVIDUAL STAPLERS FROM THE SAME LOT NUMBER THAT WERE UNDER QUARANTINE WAS RECEIVED ON 02/12/2025. VISUAL EVALUATION: PACKAGING: ALL RETURNED PRODUCTS WERE VERIFIED TO HAVE NO BREACH TO THE SEALED PACKAGING. SEAL CONDITION: THE RETURNED PRODUCT WAS VERIFIED TO DISPLAY A MINIMUM 1/8 INCH SEAL. DESICCANT PACKS: THE DESICCANT PACKS DID NOT INDICATE PROLONGED EXPOSURE TO MOISTURE. STORAGE CONDITIONS: SIX OUTER BOXES WITH TEMPERATURE INDICATORS WERE RETURNED AND ALL THE TEMPERATURE INDICATORS WERE FOUND OK AND NOT TRIGGERED. VISUAL EXAMINATION OF THE COMPLAINT PRODUCTS REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: ALL PRODUCTS WERE FUNCTIONALLY EVALUATED, ALL WERE COMPLETELY SHOT AND EMPTIED. IN ADDITION, AN AQL WAS MADE WHERE ALL THE STAPLES WERE MEASURED AND FOUND TO PASS. ANY RELEVENT CUSTOMER OR CLINICAL INFORMATION : ACCORDING TO THE FOLLOW UP EMAILS: ALL SUPPLIES ARE STORED IN A CLIMATE-CONTROLLED ENVIRONMENT. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE RETURNED PRODUCT WAS TESTED TO SPECIFICATIONS. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. COMPLAINT IS NOT CONFIRMED AS THE PRODUCT TESTED TO SPECIFICATIONS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND THE INSORB STAPLER WAS USED. SEVERAL HOURS POST-OP, THE PATIENT EXPERIENCED WOUND DEHISCENCE. DEVICE WAS DISCARDED. MULTIPLE ATTEMPTS WERE MADE, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2025-00008 2030 INSORB 2025-01-0000172.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246934 INSORB INSORB SUBCUTICULAR SKIN STAPLER GDW COOPERSURGICAL, INC. 2030 619048963 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention