BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 10295254 · Received July 20, 2020

    Report

    Report Number
    1216677-2020-00154
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 1, 2020
    Report Date
    January 13, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    UDI-DI
    00867516000104
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION: NO SAMPLE RETURNED. REVIEW DHR. ANALYSIS AND FINDINGS: 2020-07-0000125, DISTRIBUTION HISTORY, THE COMPLAINT PRODUCT WAS PURCHASED FROM EPC ON 2/14/2020. MANUFACTURING RECORD REVIEW: DHR-2030 - 285949 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW. INCOMING INSPECTION FOR THIS PRODUCT CONSISTS OF A DHR REVIEW WHICH, AS NOTED ABOVE, WAS FOUND NOT TO EXHIBIT ANY RELATED NON-CONFORMITIES. SERVICE HISTORY RECORD. SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL 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. A REVIEW OF THE PHOTOS PROVIDED BY THE ACCOUNT CONFIRMED THE COMPLAINT CONDITION OF OPEN WOUNDS. 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 AS THERE WAS NO PRODUCT RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE RELIABLY DETERMINED AT THIS TIME. PER COMMUNICATION PROVIDED BY THE ACCOUNT: THE DOCTOR WAS PREVIOUSLY TRAINED BY OUR DISTRIBUTOR AND HAD EXTENSIVE EXPERIENCE (I.E., MINIMUM 50 CASES) USING THE INSORB STAPLER. ALSO, THE PRODUCT WAS VERIFIED TO HAVE BEEN STORED AT THE CORRECT TEMPERATURE IN THE DISTRIBUTORS WAREHOUSE AND IN THE HOSPITAL. MULTIPLE CLINICAL STUDIES CAN BE FOUND ON OUR COOPERSURGICAL WEBSITE THAT PROVE THE EFFICACY AND SAFETY OF THE INSORB STAPLER. THERE HAVE BEEN NO FURTHER COMPLAINTS FILED FROM THIS ACCOUNT AGAINST THE INSORB STAPLER. FURTHERMORE, THE HOSPITAL CONTINUES TO ORDER THE INSORB STAPLER AND OVERALL ARE VERY SATISFIED WITH THE PRODUCT AS INDICATED THROUGH FEEDBACK PROVIDED FROM OUR DISTRIBUTOR. *CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME; COMPLAINT WILL BE MONITORED FOR TRENDING. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    REPORT STATED - LOCAL WOUND OPENING ABOUT A MONTH POST OPERATION. 1216677-2020-00154-1 INSORB 30 STAPLER 2030 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT STATED - LOCAL WOUND OPENING ABOUT A MONTH POST OPERATION (INCIDENT REPORT BY ANOTHER DR. (B)(6)). REFERENCE : (B)(4). INSORB 30 STAPLER 2030 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764082 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 200501 00867516000104
    764083 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 200501 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other