BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1821970 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04883
    Event Type
    Death
    Date Received
    August 31, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 8/3/2010: SPOKE TO SURGEON WHO OFFERED HIS KNOWLEDGE OF THIS PATIENT. SHE WAS A FEMALE IN HER (B)(6) WITH A BOWEL OBSTRUCTION. UNKNOWN IF AN AUTOPSY WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 8/13/2010: SURGEON HAS BEEN USING STAPLERS ALL OF HIS CAREER AND FOUND THEM TO BE VERY USEFUL. DURING CASE, THERE WAS NOT ANY PROBLEM NOTED BY THE SURGEON, NOR WAS THE PATIENT AT PARTICULAR RISK. ADDITIONAL INFORMATION BEING REQUESTED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY OF ON-SITE VISIT: SCHEDULED SITE VISIT TO EXPLORE THE OPPORTUNITY TO REVIEW EVENT DETAILS AND INVESTIGATE POTENTIAL ROOT CAUSE, PRODUCT USE PER ASSOCIATED IFU'S AND EDUCATIONAL OPPORTUNITIES. MEETING OPENED WITH AN OUTLINE OF EES' COMMITMENT TO PARTNER WITH THEIR CUSTOMERS AND TO UNDERSTAND AND MITIGATE ANY ISSUES THAT COULD COMPROMISE GOOD PATIENT OUTCOMES. DR. (B)(6) THEN OUTLINED HIS AND DR. (B)(6) PROCEDURAL PROTOCOL AND CARE THEY TAKE TO ENSURE ALL PATIENT CONDITIONS ARE CONSIDERED WHEN DECIDING PROCEDURAL TECHNIQUE AND APPROACH. FIELD QUALITY ENGINEER DISCUSSED THE PRODUCTS' MECHANICAL FUNCTIONAL FEATURES AND LIMITATIONS AS PART OF THE INVESTIGATION. SINCE OVER HALF THE EVENTS WERE POST OPERATIVE AND DEVICES NOT WERE NOT RETAINED, UTILIZED PHOTOGRAPHS OF VARYING STAPLE FORMS FOR MULTIPLE PRODUCT CODES. THE INTENT WAS TO IDENTIFY SIMILAR STAPLE FORMS TO WHAT DRS. (B)(6) EXPERIENCED TO HELP DIRECT INVESTIGATION INTO POTENTIAL ROOT CAUSE. BOTH SURGEONS WERE OFFERED AN OPPORTUNITY TO VISIT EES THAT WOULD INCLUDE A TOUR OF THE FACILITIES AND GET A BETTER UNDERSTANDING OF THE PROCESSES AND PROCEDURES THAT EES GOES THROUGH TO DEVELOP AND MAINTAIN PRODUCT QUALITY. BOTH SURGEONS INQUIRED WHETHER EES RECENTLY CHANGED ANY COMPONENT SUPPLIERS. THEIR QUESTION WAS INVESTIGATIVE IN NATURE, IN AN EFFORT TO IDENTIFY ROOT CAUSE TO THEIR RECENT EVENTS. [EES HAS NOT CHANGED SUPPLIERS AND THAT THE PRODUCTS THEY USE ARE ASSEMBLED IN EES FACILITIES ONLY.] OVERALL VISIT WAS POSITIVE AND PROVIDED EES AN OPPORTUNITY TO HEAR FIRST-HAND EVENT DESCRIPTIONS AND RECEIVE PRODUCT PERFORMANCE FEEDBACK. CUSTOMER WAS VERY APPRECIATIVE OF THE TIME AND EFFORT BY ALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A COLON RESECTION, THE SURGEON REPORTED THAT THE PATIENT EXPIRED POST OP DUE TO A SEPSIS INFECTION AT THE STAPLE LINE. NO OTHER INFORMATION WAS PROVIDED. DEVICE HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| O| R CARTRIDGE