BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOCH STOP AND CHOP MANIPULATOR HOOK

    MDR report key: 7788785 · Received August 16, 2018

    Report

    Report Number
    9612075-2018-00001
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 16, 2018
    Manufacturer
    OERTEL MEDICAL GMBH
    Product Code
    HNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. MANUFACTURING RECORDS, INCLUDING ACCEPTANCE TESTING RECORDS, WERE CHECKED FOR THE LOT IN QUESTION, CONFIRMING DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE DEVICE. THE USER HAS REFUSED TO RETURN THE DEVICE DESPITE REPEATED REQUESTS TO DO SO. PHOTOGRAPHS HAVE BEEN REQUESTED FROM THE USER AS WELL, BUT TO DATE NOTHING HAS BEEN FORTHCOMING. THEREFORE, AND DUE TO THE FACT THAT AT LEAST TWO INSTRUMENTS WERE IN USE SIMULTANEOUSLY DURING THE PROCEDURE, AT THIS TIME IT HAS NOT BEEN POSSIBLE TO CONFIRM THAT THE OPHTHALMIC HOOK SUBJECT OF THIS REPORT ACTUALLY WAS THE INSTRUMENT THAT BROKE. SHOULD ADDITIONAL INFORMATION AND/OR THE DEVICE BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE KOCH CHOPPER'S TIP ALLEGEDLY BROKE OFF IN THE PATIENT'S EYE DURING THE PROCEDURE. THIS WAS NOT DETECTED BY THE DOCTOR UNTIL THE END OF THE PROCEDURE, WHEN A FOREIGN BODY (IOFB) WAS SEEN AT THE END OF CASE RESTING ON POSTERIOR CAPSULE. AS PER INFORMATION PROVIDED BY OR STAFF, THE DOCTOR IS KNOWN FOR HITTING INSTRUMENTS WITH THE PHACO TIP DUE TO CONSISTENTLY USING INSTRUMENTS TOO CLOSE TO THE PHACO TIP DURING PROCEDURES. THE PATIENT WAS SENT HOME WITH THE IOFB LODGED IN HIS EYE AND TOLD TO COME BACK. CT SCAN OF ORBIT DONE (B)(6) 2018 SHOWED AN INFERIOR IOFB. VISCOELASTIC MATERIAL WAS INJECTED TO PROVIDE PROTECTION FOR RETRIEVAL, BUT FORCED THE IOFB INTO THE ANGLE/EQUATOR OF THE CAPSULAR BAG. THE PATIENT WAS TOLD TO COME BACK 1 MONTH LATER. BY THEN THE IOFB WAS ENCAPSULATED IN THE EYE. INTERVENTION BY A RETINAL SPECIALIST WILL BE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633250 KOCH STOP AND CHOP MANIPULATOR HOOK OPHTHALMIC HOOK HNQ OERTEL MEDICAL GMBH 02170367

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other