BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 11362489 · Received February 22, 2021

    Report

    Report Number
    1216677-2021-00041
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 22, 2021
    Report Date
    November 29, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INITIATED MANUFACTURER'S INVESTIGATION: REVIEW DHR INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS RECEIVED FROM EPC 08-03-2020 AND USED IN COOPER SURGICAL WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR-2030 - 293336 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 WAS RETURNED TO COOPERSURGICAL. VISUAL EVALUATION ALL FOUR WERE VISUALLY VERIFIED, PACKAGING, POUCH, LABELING, POUCH SEAL, STAPLER, KEEPER AND DESICCANT PACK WERE ALL ACCEPTABLE. STAPLE COUNTERS AT 30, KEEPER AND DESICCANT PACKS WERE IN PLACE AND SECURED. THE POUCH SEAL WAS ACCEPTABLE, OTHER COMPONENTS ASSOCIATED WITH THE STAPLER WERE NOT RETURNED E.G., TEMPERATURE INDICATOR. SEE ATTACHED EMAIL FOR PHOTOS. FUNCTIONAL EVALUATION ALL FOUR STAPLERS WERE FUNCTIONALLY VERIFIED AND DRY FIRED. ALL FOUR FUNCTIONED AS EXPECTED, STAPLES DEPLOYED, AND ALL STAPLE FEATURES WERE PRESENT AND FULLY FORMED. ROOT CAUSE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT IS INDETERMINABLE AS THE AFFECTED DEVICE(S) REPORTED FOR THE COMPLAINT EVENT WERE/WAS NOT RETURNED. 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? NO.

    Description of Event or Problem · 0

    "TODAY AT APPROXIMATELY 3:15 PM CENTRAL TIME I WAS CONTACTED BY THE DIRECTOR OF LABOR & DELIVERY AT (B)(6) IN (B)(6) (CUST ID#: (B)(6)). SHE REPORTED TO ME THAT THERE HAVE BEEN 3 INCISION OPENINGS AFTER USING THE INSORB STAPLER TO CLOSE ON C-SECTIONS DURING THE TIME FRAME FROM 1/22/2021 TO 2/7/2021. ONLY 1 OF THE 3 CASES HAVE EVIDENCE REGARDING THE INSORB LOT# USED ON THE PATIENT. CUSTOMER HAS ISOLATED THAT LOT (# 202501) IN HER CENTRAL SUPPLY DEPARTMENT. 02/17/2021-PER UPDATE- INCISIONAL CESAREAN SECTION DEHISCENCE. PHYSICIAN STATES INSORB STAPLER WORKED APPROPRIATELY AT TIME OF CLOSURE. HOWEVER, THE FOLLOWING DAY PHYSICIAN STATES STAPLES WERE NOT INTACT. WOUND 2.5CM X 6.5 CM. LOT # 202501 1216677-2021-00041-1 INSORB 30 STAPLER 2030 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    INCIDENT DETAIL: "TODAY AT APPROXIMATELY 3:15 PM CENTRAL TIME I WAS CONTACTED BY THE DIRECTOR OF LABOR & DELIVERY AT (B)(6). SHE REPORTED TO ME THAT THERE HAVE BEEN 3 INCISION OPENINGS AFTER USING THE INSORB STAPLER TO CLOSE ON C-SECTIONS DURING THE TIME FRAME FROM (B)(6) 2021 TO (B)(6) 2021. ONLY 1 OF THE 3 CASES HAVE EVIDENCE REGARDING THE INSORB LOT# USED ON THE PATIENT. CUSTOMER HAS ISOLATED THAT LOT (# 202501) IN HER CENTRAL SUPPLY DEPARTMENT. ADDITIONAL COMPLAINT INITIATED TO CAPTURE OTHER TWO INCIDENTS. ON (B)(6) 2021 - PER UPDATE - INCISIONAL CESAREAN SECTION DEHISCENCE. PHYSICIAN STATES INSORB STAPLER WORKED APPROPRIATELY AT TIME OF CLOSURE. HOWEVER, THE FOLLOWING DAY PHYSICIAN STATES STAPLES WERE NOT INTACT. WOUND 2.5CM X 6.5 CM. LOT # 202501. INSORB 30 STAPLER 2030 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253777 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 202501
    253798 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 202501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other