BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB 30 STAPLER

    MDR report key: 15253908 · Received August 18, 2022

    Report

    Report Number
    1216677-2022-00232
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 5, 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 REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR, INSPECT STOCK PRODUCT . *ANALYSIS AND FINDINGS : DISTRIBUTION HISTORY BASED ON THE LOT NUMBERS SHIPPED TO THE CUSTOMER, THE COMPLAINT PRODUCT (P/N 2030, INSORB 30 STAPLER) WAS MANUFACTURED AT CSI. MANUFACTURING RECORD REVIEW ALTHOUGH THE DOCTOR'S OFFICE PROVIDED NO LOT NUMBER, THE FOLLOWING DHR DOCUMENTS REPRESENT YEAR-TO-DATE LOTS SOLD TO THIS SPECIFIC CUSTOMER. DHRS WERE REVIEWED, AND NO NON-CONFORMITIES RELATED TO THE COMPLAINT CONDITION WERE NOTED. CR-DHR-2030-619001734, CR-DHR-2030-619002394, CR-DHR-2030-619002396, CR-DHR-2030-619003837, CR-DHR-2030-619003120, CR-DHR-2030-619003121, CR-DHR-2030-619003121, CR-DHR-2030-619003834, CR-DHR-2030-619003836, CR-DHR-2030-619005065, CR-DHR-2030-619005594, CR-DHR-2030-619005595, CR-DHR-2030-619005942, CR-DHR-2030-619006086, CR-DHR-2030-619007113, CR-DHR-2030-619006361, CR-DHR-2030-619007013, CR-DHR-2030-619007009, CR-DHR-2030-619007794, CR-DHR-2030-619008193, CR-DHR-2030-619005325, CR-DHR-2030-619008190. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW IS NOT APPLICABLE TO THIS PRODUCT AS THIS PRODUCT IS BEING MANUFACTURED AT CSI. SERVICE HISTORY RECORD: THE SERVICE HISTORY IS NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS (5-6 WEEKS POST OPERATION INFECTION). PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. 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 LATER, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION; HOWEVER, SAMPLES FROM THE FG INVENTORY SHELF OF THE SUSPECTED LOTS WERE PULLED AND INSPECTED. THE BOXES WERE TIGHTLY SEALED. ALSO, WHEN I OPENED THE BOXES, NO ODD APPEARANCES WERE NOTED ON THE PARTS. IN ADDITION, THE THERMO-STICKER THAT WAS PLACED IN THE OUTER BOX SHOWS A WHITE DOT. THE EVALUATED PART NUMBERS WERE (619008193 AND 619005325). THE DESICCANT PACKS ALSO DID NOT INDICATE PROLONGED EXPOSURE TO MOISTURE. FUNCTIONAL 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. ; HOWEVER, SAMPLES FROM THE FG INVENTORY SHELF OF THE SUSPECTED LOTS WERE PULLED AND EVLUATED. THE STAPLERS WERE ABLE TO BE MECHANICALLY DRY FIRED AND FUNCTIONED AS EXPECTED. THE STAPLE EVALUATION DID NOT INDICATE ANY MALFORMATION OF ANY TYPE, ALL PHYSICAL FEATURES WERE PRESENT AND AS EXPECTED. ALL STAPLES FIRED WERE FULLY FORMED. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. "ISOLATED INCIDENT." CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTIVE ACTION LEVEL 1 2 3 4. NO FURTHER TRAINING IS REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    INCIDENT 2/5. ALL OF A SUDDEN I HAVE ABOUT 5 BODY CONTOURING PATIENTS WHO HAVE HAD LATE POST OP 5 AND 6 WEEKS REJECTIONS OF THE ENSORB STAPLES ALL ALONG THEIR INCISIONS. THIS IS NEW IN THE PAST 2 MONTHS AND INCLUDES PATIENTS WHO I HAVE TAKEN CARE OF AT DIFFERENT SURGERY CENTERS. THIS HAS BEEN ALL OF A SUDDEN AND PRETTY ROBUST REACTIONS REQUIRING REMOVAL OF SEVERAL STAPLES IN THE OFFICE. I WANTED TO COMMUNICATE THIS TO SEE IF ANYONE ELSE WAS HAVING THIS ISSUE AND ALSO TO COMMUNICATE IT AND THAT I WILL LIKELY BE USING 3-0 VICRYL INSTEAD FOR MY CLOSURES ON THE ABDOMINOPLASTY AND BODY LIFTS IN PLACE OF THE STAPLES AS FAR AS UPDATING MY PREFERENCE CARDS AND TO PREVENT WASTE WITH ENSORB STAPLES BEING OPENED UNNECESSARILY. FOLLOW-UP: DR. (B)(6) HAS BEEN USING INSORB FOR OVER 1.5 YEARS IN OVER 100 CASES WITHOUT ISSUES. ALSO USED WHILE IN TRAINING IN RESIDENCY. ALL 4-6 WEEKS IN. 2 IN THE LAST FEW WEEKS BEGINNING THE INFECTION AT 6 WEEKS. SELF CLOSED ALL CASES, NO ASSISTANT CLOSED. ALL OCCURRED IN PAST 2 MONTHS. UNFORTUNATELY NO LOT #'S WERE RECORDED, NO DEVICES WERE RETAINED. 4 OF THE 5 REPORTED EVENTS OCCURRED AT SURGERY (B)(6) TX. ALL 4-6 WEEKS IN, 2 IN THE LAST FEW WEEKS BEGINNING THE INFECTION AT 6 WEEKS. 1 PATIENT HAD ENTIRE 360 INCISION INFLAMED, 2 WITH ONGOING CURRENT WOUNDS, 1 CURRENT WITH A COURSE OF ANTIBIOTICS. INSORB 30 STAPLER 2030 E-COMPLAINT-2022-08-0000303.

    Description of Event or Problem · 0

    INCIDENT 2/5. ALL OF A SUDDEN I HAVE ABOUT 5 BODY CONTOURING PATIENTS WHO HAVE HAD LATE POST OP 5 AND 6 WEEKS REJECTIONS OF THE ENSORB STAPLES ALL ALONG THEIR INCISIONS. THIS IS NEW IN THE PAST 2 MONTHS AND INCLUDES PATIENTS WHO I HAVE TAKEN CARE OF AT DIFFERENT SURGERY CENTERS. THIS HAS BEEN ALL OF A SUDDEN AND PRETTY ROBUST REACTIONS REQUIRING REMOVAL OF SEVERAL STAPLES IN THE OFFICE. I WANTED TO COMMUNICATE THIS TO SEE IF ANYONE ELSE WAS HAVING THIS ISSUE AND ALSO TO COMMUNICATE IT AND THAT I WILL LIKELY BE USING 3-0 VICRYL INSTEAD FOR MY CLOSURES ON THE ABDOMINOPLASTY AND BODY LIFTS IN PLACE OF THE STAPLES AS FAR AS UPDATING MY PREFERENCE CARDS AND TO PREVENT WASTE WITH ENSORB STAPLES BEING OPENED UNNECESSARILY. FOLLOW-UP: DR. (B)(6) HAS BEEN USING INSORB FOR OVER 1.5 YEARS IN OVER 100 CASES WITHOUT ISSUES. ALSO USED WHILE IN TRAINING IN RESIDENCY. ALL 4-6 WEEKS IN. 2 IN THE LAST FEW WEEKS BEGINNING THE INFECTION AT 6 WEEKS. SELF CLOSED ALL CASES, NO ASSISTANT CLOSED. ALL OCCURRED IN PAST 2 MONTHS. UNFORTUNATELY NO LOT #'S WERE RECORDED, NO DEVICES WERE RETAINED. 4 OF THE 5 REPORTED EVENTS OCCURRED AT SURGERY CTR OF TX. ALL 4-6 WEEKS IN 2 IN THE LAST FEW WEEKS BEGINNING THE INFECTION AT 6 WEEKS. 1 PATIENT HAD ENTIRE 360 INCISION INFLAMED . 2 WITH ONGOING CURRENT WOUNDS . 1 CURRENT WITH A COURSE OF ANTIBIOTICS . INSORB 30 STAPLER 2030 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995612 INSORB 30 STAPLER INSORB 30 STAPLER GAG COOPERSURGICAL, INC. 2030 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other