BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 11086819 · Received December 29, 2020

    Report

    Report Number
    1216677-2020-00302
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    September 11, 2020
    Report Date
    January 23, 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

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION NO SAMPLE RETURNED REVIEW DHR. 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 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR-2030 - 287120, DHR-2030 - 201701, DHR-2030 - 287120, DHR-2030 - 202001, AND DHR-2030 - 202101 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION WERE NOTED. FURTHERMORE, DHRS OF THE PRODUCTS ORDERED BETWEEN MARCH-OCTOBER 2020 WERE REVIEWED AS WELL 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. PRODUCT RECEIPT THE COMPLAINT PRODUCTS (4 SEALED STAPLERS) WERE RETURNED ON 12-19-20. THE LOT NUMBER OF THE RETURNED PRODUCTS WERE 200801, 201701, 202001, AND 202101. 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 HOWEVER FOLLOW-UP WITH ACCOUNT INDICATED THE PRODUCTS WERE STORED IN A TEMPERATURE CONTROLLED ROOM. VISUAL EXAMINATION OF THE COMPLAINT PRODUCTS REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION THE COMPLAINT PRODUCTS WERE FUNCTIONALLY EVALUATED AND WERE FOUND TO FUNCTION PROPERLY. ALL 30 STAPLES FIRED AS EXPECTED WITH EACH STAPLER. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, THE RETURNED PRODUCTS TESTED TO SPECIFICATION. CORRECTION AND/OR CORRECTIVE ACTION COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL SO THE COMPLAINT COULD NOT BE CONFIRMED. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTIONS NECESSARY. NO FURTHER TRAINING IS REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    REP REPORTED: I WAS CONTACTED THIS AFTERNOON BY A GYNECOLOGIST WITH WOMEN'S HEALTH SPECIALIST OF DALLAS ABOUT MULTIPLE DEHISCENCE/WOUND CLOSURES USING THE INSORB STAPLER ON C SECTIONS AT TEXAS HEALTH RESOURCES PRESBYTERIAN DALLAS HOSPITAL. WHEN SHE CALLED SHE DIDN'T HAVE THE EXACT DATES THESE EVENTS OCCURRED.OCCURRENCE 1-C SECTION DATE: 09/11/2020,DATE OF DEHISCENCE: 9/28/20 SEROMA 3BY6BY2CM,DISPO: DAILY DRESSING CHANGES AT HOME. SECONDARY CLOSURE ON 10/6/20RISK FACTORS BMI 41INDICATION FOR C SECTION: SUSPECTED CONTRACTED PELVIS, SCHEDULED C SECTION NEVER LABORED1216677-2020-00302-1 INSORB 30 STAPLER 2030 E-COMPLAINT-2020-12-0000053

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    ADDITION COMPLAINT IN REF TO (B)(4) ( OTHER OCCURRENCES ATTRIBUTED TO CLAIMED FAILURE OF PRODUCT). REPORT SUBMITTED BY (B)(6). INCIDENT REPORT- I WAS CONTACTED THIS AFTERNOON BY DR (B)(6), A GYNECOLOGIST WITH (B)(6) ABOUT MULTIPLE DEHISCENCE/WOUND CLOSURES USING THE INSORB STAPLER ON C SECTIONS AT (B)(6) HOSPITAL. WHEN SHE CALLED SHE DIDN'T HAVE THE EXACT DATES THESE EVENTS OCCURRED. OCCURRENCE 1: C SECTION, SURGEON (B)(6), DATE OF DEHISCENCE (B)(6) 2020 SEROMA 3BY6BY2CM, DISPO: DAILY DRESSING CHANGES AT HOME. SECONDARY CLOSURE ON (B)(6) 2020, RISK FACTORS BMI 41, INDICATION FOR C SECTION: SUSPECTED CONTRACTED PELVIS, SCHEDULED C SECTION NEVER LABORED. INSORB 30 STAPLER 2030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550710 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 NOT PROVIDED 00867516000104
    1550721 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2020 NOT PROVIDED 00867516000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| L