BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 16050617 · Received December 27, 2022

    Report

    Report Number
    1216677-2022-00326
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    December 1, 2022
    Report Date
    March 2, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    UDI-DI
    00867516000104
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON JUNE 07TH, 2022 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR CR_DHR_2030_619010362 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC 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 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. SIMILAR ISSUES WERE FOUND ALSO FOR OTHER INSORB CODES RELATED TO DOES NOT PERFORM PROPERLY. ON THE COMPLAINTS REVIEWED THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. FUNCTIONAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NOT TRAINING REQUIRED FOR THIS COMPLAINT. *WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 0

    NOT FIRING CORRECTLY. "WE WERE ABLE TO COMPLETE THE CLOSURE WITH TRADITIONAL SUTURE CLOSURE. WE DID HAVE A SHORT DELAY OF APPROXIMATELY 10 MINUTES ON EACH CASE." PROCEDURE 2 OF 3 1216677-2022-00326-1 INSORB 30 STAPLER 2030 (B)(4).

    Description of Event or Problem · 0

    DETAILS OF THE COMPLAINT: "NOT FIRING CORRECTLY." "THE STAPLERS WERE USED ON 3 SEPARATE PATIENTS WITH NO NEGATIVE EFFECTS. WE WERE ABLE TO COMPLETE THE CLOSURE WITH TRADITIONAL SUTURE CLOSURE. WE DID HAVE A SHORT DELAY OF APPROXIMATELY 10 MINUTES ON EACH CASE." 1216677-2022-00326 INSORB 30 STAPLER 2030 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199778 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 619010362 00867516000104
    2789129 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 619010362 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other