BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 13757435 · Received March 14, 2022

    Report

    Report Number
    1216677-2022-00065
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 20, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INITIATED MANUFACTURER'S INVESTIGATION NO SAMPLE RETURNED REVIEW DHR INSPECT STOCK PRODUCT ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM COOPER MEDICAL SRL ON 10-11-2021 AND SOLD ON 11-15-21. MANUFACTURING RECORD REVIEW DHR-7757 WAS REVIEWED AND ONE NON-CONFORMITY, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. THERE WERE NO NON-CONFORMANCE'S RELATED TO THE MANUFACTURE OF THIS LOT, HOWEVER IT WAS NOTED AT THE TIME OF RECEIPT IN TRUMBULL THAT SOME OF THE DATA LOGGERS USED TO MONITOR SHIPMENT TEMPERATURES WENT ABOVE THE SPECIFIED LIMIT. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. 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. THERE WERE ADDITIONAL INSTANCES OF STAPLERS MISFIRING OR NOT FIRING THE TOTAL QUANTITY OF STAPLES. THE ROOT CAUSES COULD NOT RELIABLY BE DETERMINED. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. VISUAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. 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 COOPER SURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. ROOT CAUSE WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE RELATED TO EXPOSURE TO EXCESSIVE TEMPERATURE DURING SHIPPING. CORRECTIVE ACTIONS COOPER SURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT. THE STAPLER DID NOT FIRE CORRECTLY. ANOTHER STAPLER FROM THE SAME LOT WAS USED AND HAD THE SAME ISSUE. AT THAT POINT THE SURGEON CLOSED WITH SUTURE. 1216677-2022-00065 INSORB 30 STAPLER 2030 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT THE STAPLER DID NOT FIRE CORRECTLY. ANOTHER STAPLER FROM THE SAME LOT WAS USED AND HAD THE SAME ISSUE. AT THAT POINT THE SURGEON CLOSED WITH SUTURE. DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING. PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? YES. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? NO. MEDICAL OR PROCEDURAL INTERVENTION? NO. PATIENT/GAMETE/EMBRYO STATUS NO HARM TO PATIENT. SURGERY COMPLETED/PATIENT STABLE. FOLLOW-UP RESPONSE- THE PROCEDURE WAS: ABDOMINOPLASTY WITH LIPOSUCTION, BILATERAL BREAST AUGMENTATION WITH MASTOPEXY THE DELAY TO THE CASE WAS APPROXIMATELY 15 MINUTES INSORB 30 STAPLER 2030 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393959 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 7577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other