BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 13825501 · Received March 19, 2022

    Report

    Report Number
    1216677-2022-00086
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    March 3, 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

    INITIATED MANUFACTURER'S INVESTIGATION: REVIEW DHR AND INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM EPC ON 10/11/21 AND SOLD ON 10/18/21. NO ADDITIONAL UNITS FROM THIS LOT COULD BE LOCATED IN INVENTORY. MANUFACTURING RECORD REVIEW: DHR-213401 (FROM EPC) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 THE STAPLERS NOT FIRING OR CEASING TO FUNCTION BEFORE ALL THE STAPLES WERE USED. THE ROOT CAUSES COULD NOT BE DETERMINED. PRODUCT RECEIPT: THE COMPLAINT PRODUCT (1 STAPLER) WAS RETURNED (OPENED/USED) ON 3/29/2022. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER FROM THE COMPLAINT. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. THE UNIT WAS SOILED WITH DRIED BLOOD. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. AFTER WIPING OFF AS MUCH BLOOD AS POSSIBLE, WHEN THE HANDLE WAS ENGAGED THE STAPLER SUCCESSFULLY FIRED 3 ADDITIONAL STAPLES BEFORE REPEATEDLY DRY-FIRING. IT COULD NOT BE DETERMINED HOW MANY TOTAL STAPLES HAD BEEN USED OR IF THE STAPLER WAS EMPTY DUE TO THE BLOOD IN THE GROOVE. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. IT SHOULD BE NOTED THAT TEST CONDITIONS COULD NOT ACCURATELY SIMULATE REAL WORLD USE IN HUMAN TISSUE. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTIONS: COOPERSURGICAL 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. STAPLE MALFUNCTION DURING SURGERY. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? YES. SUTURES WERE USED INSTEAD OF STAPLER. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES DELAY? YES. 15 MINUTE DELAY. INSORB 30 STAPLER 2030. E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT: STAPLE MALFUNCTION DURING SURGERY. 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? YES. PATIENT/GAMETE/EMBRYO STATUS: PATIENT WAS NOT HARMED.. FOLLOW-UP RESPONSE: PER YOUR RESPONSE: "MEDICAL OR PROCEDURAL INTERVENTION? YES." PLEASE STATE DETAILS OF MEDICAL INTERVENTION: NO, MY APOLOGIES. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? BREAST REDUCTION. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? YES. SUTURES WERE USED INSTEAD OF STAPLER. WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NO. SUTURES WERE USED INSTEAD OF STAPLER. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES DELAY? YES. 15 MINUTE DELAY. 1216677-2022-00086-1 INSORB 30 STAPLER 2030 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290897 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 213401
    2715418 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 213401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other