BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENDED SIDE FREEZE CYRO PROBE

    MDR report key: 65605 · Received December 31, 1996

    Report

    Report Number
    65605
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 19, 1996
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Product Code
    HQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN 8/1/96 FOR A RETINAL DETACHMENT (OD) PROCEDURE. DURING THE CASE, ONE OR BOTH OF THE EXTENDED SIDE FREEZE CYRO PROBES WOULD NOT FREEZE, RESULTING IN UNNECESSARY MULTIPLE ATTEMPTS TO FREEZE. THEN, CAUSING A RUPTURE OF THE SCLERA. PT REQUIRED TISSUE TRANSPLANT TO REPAIR THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDED SIDE FREEZE CYRO PROBE FREEZING PROBES HQA KEELER INSTRUMENTS, INC. NONE NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention