BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 9480278 · Received December 17, 2019

    Report

    Report Number
    1216677-2019-00316
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    July 16, 2019
    Report Date
    May 17, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GDW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: (B)(4). *INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION. X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY: THE COMPLAINT (B)(4) WAS MANUFACTURED BY EPC AND COMPLETED 6/6/2019 TO 6/18/2019 AND SHIPPED ON 6/27/2019 UNDER WORK ORDER 192301 BY EPC FOR INCISIVE PRIOR TO PRODUCT ACQUISITION BY CSI, INC. MANUFACTURING RECORD REVIEW: DHR-192301 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SEE ATTACHED. INCOMING INSPECTION REVIEW IQC-2030 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE PRODUCT TWO-YEAR HISTORY INDICATED THAT SIMILAR EVENT WAS REPORTED BUT DID NOT REVEAL ANY TRENDS. THE REPORTED EVENT WILL BE MONITORED FOR POSSIBLE FUTURE REPORTED EVENT TRENDING. PRODUCT RECEIPT: THE SAMPLE WAS RETURNED 12/18/2019 AS NOTED IN DATAWORKS. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT 2030 WAS PERFORMED, TWO SAMPLES WERE RETURNED POUCHED AND SEALED. VISUAL VERIFICATION OF BOTH THE POUCHES AND THE TWO STAPLERS DID NOT INDICATE ANY OBVIOUS DAMAGE, LABELING INFO WAS CORRECT. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT 2030 WAS PERFORMED AND BOTH STAPLERS FUNCTIONED AS INTENDED. THE REPORTED EVENT COULD NOT BE DUPLICATED. SEE ATTACHED PHOTOS OF DEPLOYED STAPLES. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED THROUGH ACCEPTABLE FUNCTIONAL TESTING. IT SHOULD BE NOTED THAT THE STAPLE LOT IS DIMENSIONALLY AND FUNCTIONALLY SAMPLE TESTED FOR STRENGTH DURING STAPLE PRODUCTION AND IQC VERIFICATION OF FINISHED PRODUCT. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REPORT STATED- "STAPLERS NOT FIRING, NOT RELEASING STAPLES". "RE-CLOSURE PERFORMED BY SUTURE." REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. REFERENCE: E-COMPLAINT (B)(4).

    Description of Event or Problem · 1

    REPORT STATED- "STAPLERS NOT FIRING, NOT RELEASING STAPLES". "RE-CLOSURE PERFORMED BY SUTURE." REFERENCE :E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280018 INSORB 30 STAPLER INSORB 30 STAPLER GDW COOPERSURGICAL, INC. 2030 192301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other