BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 20 CM, INLINE GRIP

    MDR report key: 3131470 · Received May 8, 2013

    Report

    Report Number
    8010047-2013-00145
    Event Type
    Other
    Date Received
    May 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO. THE USER FACILITY REPORTED THAT THE REFERENCED DEVICE WAS DISPOSED OF AS THE ORIGINAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INDICATION OF DEVICE MALFUNCTION. THERE WAS NO ERROR MESSAGE/CODE DISPLAYED DURING THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE PT HAD A MALFORMATION OF ONE OF THE LUNGS WITH AN ABNORMALLY LARGE PULMONARY ARTERY. THE PT WAS SAID TO HAVE UNDERGONE A THERAPEUTIC LAPAROSCOPIC LOBECTOMY PROCEDURE ON (B)(6) 2013 WHERE AN UNSPECIFIED MONOPOLAR HOOK WAS USED FOR DISSECTION, THE PULMONARY ARTERY WAS CLIPPED AT THE BASE USING A TELEFLEX MEDICAL WECK HEMO-O-LOK ML LIGATING CLIP, AND THE SUBJECT DEVICE WAS USED TO SEAL. THERE WAS NO BLEEDING VISUALIZED DURING THE PROCEDURE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED SUCCESSFULLY. ON (B)(6) 2013, ONE WEEK FOLLOWING THE ORIGINAL PROCEDURE, THE PT WAS SAID TO HAVE HAD NO VITALS. AN OPEN THORACOTOMY WAS SAID TO HAVE BEEN PERFORMED AND IT WAS DISCOVERED THAT THE PULMONARY ARTERY WAS BLEEDING WITH NO CLIP FOUND. THE BLEEDING WAS SAID TO HAVE BEEN CONTROLLED AND THE PT WAS RESUSCITATED. THE PT WAS SAID TO HAVE BEEN IN STABLE CONDITION. THERE WAS NO KNOWN CAUSE FOR THE DELAYED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202410 OLYMPUS THUNDERBEAT 5 MM, 20 CM, INLINE GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-05201C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO OLYMPUS USG-400| OLYMPUS ESG-400| UNSPECIFIED MONOPOLAR HOOK| TELEFLEX MEDICAL WECK HEMO-O-LOK ML LIGATING CLIP:| MODEL #544230| CONMED ELECTROSURGICAL UNIT| OLYMPUS TD-TB400