BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 12614248 · Received October 12, 2021

    Report

    Report Number
    1216677-2021-00224
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 15, 2021
    Report Date
    January 9, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    UDI-DI
    00867516000104
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 BY EPC UNDER LOT 212301 FOR CSI IN JUNE/JULY 2021 (QUALITY WORK ORDER (B)(4)). MANUFACTURING RECORD REVIEW: DHR FROM IQC (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC RECORD-21-07-27-004 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 FROM THE SAME ACCOUNT FOR THE SAME LOT NUMBER. THERE WERE NO OTHER COMPLAINTS FOR THIS LOT NUMBER FROM ANY OTHER ACCOUNT. 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. 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: ROOT CAUSE CANNOT BE RELIABLY DETERMINED AS THE PRODUCT HAS NOT BEEN RETURNED. HOWEVER, COMPLAINT HISTORY SHOWS MULTIPLE COMPLAINTS FROM THE SAME ACCOUNT FOR THE SAME LOT NUMBER. THERE ARE NO OTHER COMPLAINTS FOR THIS LOT NUMBER. BASED ON THIS INFORMATION AND THE COMPLAINT DESCRIPTION, THE ISSUE COULD BE ATTRIBUTED TO THE INSTRUMENT POSSIBLY BEING EXPOSED TO EXCESSIVE TEMPERATURES WHICH CAN CAUSE DEFORMATIONS IN THE STAPLE AND AFFECT THE ASSEMBLY. THE IFU STATES TO "STORE AT 61-77°F" AND "DO NOT EXPOSE TO 122°F - AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES. DO NOT USE THE STAPLERS IF THE TEMPERATURE CIRCLE ON THE FRONT FLAP OF THE CARTON HAS CHANGE TO RED." 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. NO TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    SOME OF THE STAPLES WERE STUCK IN THE NOSE AND THEN THEY COULDN'T REMOVE THE DEVICE FROM THE PATIENT. WHEN THEY TESTED IT OUTSIDE THE PATIENT, A STAPLER DIDN'T ALWAYS COME OUT. THE PATIENT WASN'T INJURED. SOME OF THE WOUNDS OPENED AGAIN AND HE HAD TO PUT EXTRA STERI-STRIPS. 1216677-2021-00224-1 INSORB 30 STAPLER 2030 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    SOME OF THE STAPLES WERE STUCK IN THE NOSE AND THEN THEY COULDN'T REMOVE THE DEVICE FROM THE PATIENT. WHEN THEY TESTED IT OUTSIDE THE PATIENT THERE DIDN'T ALWAYS COME A STAPLE OUT. THE PATIENT WASN'T INJURED. 09/23/2012- FOLLOW-UP RESPONSE- (B)(4). WAS THERE PATIENT INVOLVEMENT IN EVERY REPORTED CONDITION? YES. WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? YES, SOME OF THE WOUNDS OPENED AGAIN AND HE HAD TO PUT EXTRA STERI-STRIPS. WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? YES, DR HAD TO CLOSE THE WOUNDS AGAIN A DAY LATER WITH STERI-STRIPS. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES DELAY?" NO, NOT 30MINUTES, BUT IT TOOK THEM LONGER TO CLOSE THE WOUNDS. INSORB 30 STAPLER 2030. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518370 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 212301 00867516000104
    1518371 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 212301 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other