BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 15476655 · Received September 24, 2022

    Report

    Report Number
    1216677-2022-00264
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    September 8, 2022
    Report Date
    January 5, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GAG
    UDI-DI
    00867516000104
    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 REVIEW DHR INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS- DISTRIBUTION HISTORY THE LOT NUMBER OF THE PRODUCTS USED ARE UNKNOWN HOWEVER THE CUSTOMER SENT BACK A SAMPLING OF THEIR INVENTORY. THE COMPLAINT PRODUCTS WERE MANUFACTURED AT CSI. MANUFACTURING RECORD REVIEW A SPECIFIC LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER HOWEVER, ACCORDING TO THE SAMPLE SENT: DHR-2030 - 619009267, DHR-2030 - 619009266, DHR-2030 - 619020360, DHR-2030 - 619009265, AND DHR-2030 - 619003833, DHR-2030 - 619007795, DHR-2030 - 619008193, DHR-2030 - 619003118 WERE 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 WERE THE STAPLER STOPPED WORKING. PRODUCT RECEIPT THE COMPLAINT PRODUCTS WERE RETURNED ON 10/05/22. THE LOT NUMBER OF THE RETURNED PRODUCTS WERE: RECEIVED LOT NUMBER QUANTITY 619009267 6. 619009266 6. 619010360 6. 619009265 5. 619003833 2. 619007795 1. 619008193 1. 619003118 1. VISUAL EVALUATION PACKAGING: ALL RETURNED PRODUCT WAS VERIFIED TO HAVE NO BREACH TO THE SEALED PACKAGING. SEAL CONDITION: THE RETURNED PRODUCT WAS VERIFIED TO DISPLAY A MINIMUM 1/8 INCH SEAL. DESICCANT PACKS: THE DESICCANT PACKS DID NOT INDICATE PROLONGED EXPOSURE TO MOISTURE. STORAGE CONDITIONS: OUTER BOX WITH TEMPERATURE INDICATOR WAS NOT RETURNED. VISUAL EXAMINATION OF THE COMPLAINT PRODUCTS REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION THE COMPLAINT PRODUCTS WERE FUNCTIONALLY EVALUATED AND TESTED BY THE QUALITY INSPECTORS AND A REPORT WAS ISSUED FOR EVERY LOT NUMBER PROVIDED (SEE ATTACHMENTS) AND WERE FOUND TO FUNCTION PROPERLY. IN LOT 619009265 ONE OF THE STAPLERS PRESENTED 2 STAPLES THAT FAILED THE PENETRATOR GAP AND STAPLE MEASUREMENTS BY 0.001 INCH, BUT THE REST WERE FOUND TO FUNCTION PROPERLY. ALL THE STAPLERS WERE COMPLETELY FIRED AND FOUND TO FUNCTION CORRECTLY. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME AS THE FAULTY LOT NUMBERS WERE NOT PROVIDED. HOWEVER, IT IS WORTH MENTIONING THAT THE RETURNED PRODUCTS TESTED TO SPECIFICATION. CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    WHAT ARE THE DETAILS OF THE COMPLAINT? THIS MORNING I RECEIVED A CALL FROM DR PADILLA WILLIAMS WHO STATED THAT A PATIENT THAT HAD INSORB USED ON THEIR C-SECTION INCISION ABOUT 28 HOURS AGO HAD ALL THE STAPLES OPENED UP AND DISPLACED LEAVING THE INCISION WIDE OPEN. SHE STATED THAT IT WAS REALLY WEIRD HOW THE STAPLES LOOKED LIKE THEY PROBABLY WOULD AFTER ABOUT 2-3 WEEKS POST OP. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? C-SECTION . DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? NONE REPORTED. HOW IS PATIENT TODAY? UNKNOWN . WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? UNKNOWN. INSORB 30 STAPLER 2030 E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    REP REPORTED: THIS MORNING I RECEIVED A CALL FROM DR [ ] WHO STATED THAT A PATIENT THAT HAD INSORB USED ON THEIR C-SECTION INCISION ABOUT 28 HOURS AGO HAD ALL THE STAPLES OPEN UP AND DISPLACE, LEAVING THE INCISION WIDE OPEN. DR [ ] STATED THAT IT WAS REALLY WEIRD HOW THE STAPLES LOOKED LIKE THEY PROBABLY WOULD AFTER ABOUT 2-3 WEEKS POST OP. INSORB 30 STAPLER 2030 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651654 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 UNKNOWN 00867516000104
    2616352 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 UNKNOWN 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other