BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB 30 STAPLER

    MDR report key: 18024694 · Received October 27, 2023

    Report

    Report Number
    1216677-2023-00144
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 2, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GDW
    UDI-DI
    00867516000104
    PMA / PMN Number
    K120373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: FRANCE. CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED AND CAN NOT BE RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED BY CSI. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER PROVIDED WAS NOT VALID. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. 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. HOWEVER, IN THOSE CASES THE PRODUCT WAS NOT RETURNED AND RULED NOT TO BE A MANUFACTURING ISSUE. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS NOT RETURNED TO CSI. 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 COMP:LAINT 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 : NO ROOT CAUSE COULD BE RELIABLY DETERMINED. THE IFU INDICATES PROPER SKIN CLOSURE TECHNIQUE AND THE GUIDELINES TO MINIMIZE SUPERFICIAL OR EXTERNAL STAPLE PLACEMENTS WHICH MENTIONS TO KEEP THE STAPLER LEVEL WITH PLANE OF SKIN AND TO ENSURE THAT THE BLUE TRIANGLES (BOTH) ARE COVERED BY SKIN. NO INFORMATION ABOUT HOW THE STAPLES WERE REMOVE WAS PROVIDED NOR THE PROCEDURE FOLLOWED BY THE PHYSICIAN. HOWEVER, FOR THE POST OPERATIVE WOUND ACCESS, THE IFU MENTIONS TO USE SCISSORS TO CUT THE BACKSPAN OF THE STAPLE AND THAT IT'S NOT NECESSARY TO REMOVE THE STAPLE FRAGMENTS. REMOVING THEM WILL CAUSE AN UNDESIRED TENSION TO THE WOUND THAT COULD LEAD TO BLEEDING AS IT WAS MENTIONED BY THE CLIENT IN THE FOLLOW UPS. NO CORRECTIVE ACTION NEEDED AS NO PRODUCT WAS RECEIVED FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER THAT COULD SHOW THE CONDITION DESCRIBED. ALSO, NO EVIDENCE OF MANUFACTURING DEFECT WAS FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    PATIENT 2/2: IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN SECTION DELIVERY ON AN UNKNOWN DATE. APPROXIMATELY 6 TO 8 WEEKS POSTOPERATIVE SHE PRESENTS EXTERNALIZED STAPLES TO THE SKIN AT THE LEVEL OF THE SCAR. MANUAL REMOVAL OF EXTERNALIZED STAPLES. THE PATIENT UNDERWENT PROCEDURE TO MANUALLY SUTURE WOUND AND EXPERIENCED BLEEDING DURING MANUAL STAPLE REMOVAL. THIS WAS PAINFUL FOR THE PATIENT. STAPLES WERE DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 2030 INSORB 2023-08-0000499

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138222 INSORB 30 STAPLER SKIN STAPLER/STAPLE, BIOABSORBABLE GDW COOPERSURGICAL, INC. 2030 22280 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention