BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRASPING FORCEPS

    MDR report key: 11930305 · Received June 3, 2021

    Report

    Report Number
    8010047-2021-07057
    Event Type
    Injury
    Date Received
    June 3, 2021
    Report Date
    July 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170032165
    PMA / PMN Number
    K962533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO REPORT INVESTIGATION FINDINGS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. THE DEFINITIVE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE LITERATURE TITLED "ENDOLUMINAL APPENDECTOMY: THE FIRST DESCRIPTION IN HUMANS FOR ACUTE APPENDICITIS", A PATIENT EXPERIENCED ABDOMINAL PAIN AND LOW GRADE FEVER ON THE FIRST POST-OPERATIVE DAY REQUIRING MEDICAL INTERVENTION. IN THIS CASE STUDY, A (B)(6) YEAR-OLD MALE PRESENTED WITH VAGUE LOWER ABDOMINAL PAIN AND FEVER. TWO DAYS EARLIER, AN ULTRA SONOGRAPHY SHOWED AN ENLARGED APPENDIX. A COLONOSCOPY WAS PERFORMED TO INVESTIGATE SYNCHRONIC LESIONS AND SHOWED ONLY A PURULENT DISCHARGE FROM THE APPENDICEAL ORIFICE. PATHOLOGICAL ASSESSMENT CONFIRMED ACUTE APPENDICITIS. THE AUTHORS DESCRIBED THE FIRST PROCEDURE TO REMOVE THE APPENDIX USING COLONOSCOPY DURING ACUTE APPENDICITIS PRESENTATION USING A HANDMADE DOUBLE CHANNEL COLONOSCOPE PROTOTYPE WITH AN ADAPTED 20 FR NASOGASTRIC TUBE, ALONG WITH OLYMPUS SHARK TOOTH GRASPING FORCEPS, ENDOCLIPS, AND ENDOLOOP AND A BOSTON SCIENTIFIC STANDARD DIATHERMIC SNARE WIRE LOOP. THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT AND LOW-GRADE FEVER ON THE FIRST POSTOPERATIVE DAY. HE RECEIVED CEFTRIAXONE 2 G/DAY AND METRONIDAZOLE 1.5 G/DAY FOR 2 DAYS; ORAL DIET WAS STARTED ON THE SAME DAY. ON THE SECOND POSTOPERATIVE DAY, THE PATIENT¿S CONDITION IMPROVED, WITHOUT ANY REPORT OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827443 GRASPING FORCEPS GRASPING FORCEPS EOQ OLYMPUS MEDICAL SYSTEMS CORP. FG-32C-1 UNKNOWN(LITERATURE) 04953170032165

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R