BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 41142 · Received September 13, 1996

    Report

    Report Number
    1628808-1996-00042
    Event Type
    Malfunction
    Date Received
    September 13, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 13, 1996
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS DOING WELL. SURGEON STATED THE STAPLES WERE PRESENT IN THE TISSUE, BUT NOT COMPLETELY FORMED. PATIENT INFO: MALE, 143#, FIRST SUGERY FOR COLON CA, HX OF HTN. TSB D5,6;H4: INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    8/19/96 1601 MESSAGE AND 900# LEFT FOR MD CALL BACK. TSB 8/20/96 NNCL SENT TO MD. KJB 8/19/96 1621 THE CONTACT PERSON, WAS GONE FOR THE DAY. WAS ASKED TO CALL BACK TOMORROW. TSB 8/19/96 1628 CIN SPOKE WITH RISK MANAGER, SHE WAS UNAWARE OF THE REPORTED EVENT AND STATED SHE WOULD LOOK FURTHER FOR ADDITIONAL INFORMATION. TSB 8/20/96 1205 CIN SPOKE WITH CONTACT AND SHE STATED SHE DID NOT HAVE ACCESS TO THE INFORMATION NEEDED. SHE SUGGESTED CONTACTING THE SURGEONS OFFICE. BAH 8/20/96 1210 CIN SPOKE WITH THE SURGEONS OFFICE REQUESTING PATIENT INFORMATION. BAH 8/21/96 1105 DR CALLED BACK AND CONFIRMED THE INFORMATION AS REPORTED BY THE REP. HE STATED WHEN THE RESIDENT FIRED THE INSTRUMENT IT DID NOT FEEL RIGHT, IT DID NOT CLOSE ALL THE WAY, THE WASHER CRUNCH WAS NOT HEARD. WHEN THE INSTRUMENT WAS REMOVED, THE ANVIL WOULD NOT COME OUT AND IT HAD TO BE EXCISED. THE ANASTAMOSIS WAS THEN HAD SEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLER GAG ETHICON ENDO SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other