BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 7083483 · Received December 5, 2017

    Report

    Report Number
    2951238-2017-00754
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 8, 2017
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    PK063786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION PROVIDED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). NO DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION TO DATE. THE OEM PERFORMED AN INVESTIGATION BASED ON THE AVAILABLE INFORMATION. THE OEM CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR THE CONCERN SERIAL NUMBER AND FOUND NO ABNORMALITIES DURING THE MANUFACTURING PROCESS. THE COMPLAINTS RECORDS WERE REVIEWED WITH NO SIMILAR EVENTS RELATED TO THE REPORTED EVENT AND REPORTED DEVICE. THE DEVICE WAS SOLD IN DECEMBER 27, 2012 WITH NO SERVICE RECORDS. BASED ON REPORTED INFORMATION, THERE IS A HIGH POSSIBILITY THAT THE PERFORATION TO THE PATIENT¿S COLON WAS CAUSED BY THE OPERATOR¿S TECHNIQUE AND NOT CAUSED BY THE UCR DEVICE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FCX TO HIF.

    Additional Manufacturer Narrative · 1

    THE REFERENCED CO2 REGULATION UNIT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, USER HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THE INSTRUCTION MANUAL WARNS USERS WHEN THE ENDOSCOPIC CO2 REGULATION UNIT IS USED IN COMBINATION WITH THE UPPER/LOWER GASTROINTESTINAL ENDOSCOPE THAT, 1) OVER-INSUFFLATING THE LUMEN MAY CAUSE PATIENT PAIN, INJURY, BLEEDING, GAS EMBOLISM AND/OR PERFORATION. 2) ANYTIME YOU OBSERVE AN IRREGULARITY IN THE ENDOSCOPIC CO2 REGULATION UNIT, IMMEDIATELY STOP USING THE ENDOSCOPIC REGULATION UNIT AND WITHDRAW THE ENDOSCOPE FROM THE PATIENT SLOWLY AS DESCRIBED IN THE ENDOSCOPE¿S INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE PATIENT¿S CECUM WAS PERFORATED DURING A COLONOSCOPY PROCEDURE. THE PATIENT HAD TWO POLYPS REMOVED USING AN OLYMPUS COLONOSCOPE (CF-HQ190L), CO2 REGULATION UNIT (UCR) AND A NON-OLYMPUS HOT SNARE. HOWEVER, FOLLOWING THE PROCEDURE THE PATIENT COMPLAINED OF ABDOMINAL PAIN. NO ADDITIONAL PROCEDURES WERE PERFORMED FOR THE PERFORATION; HOWEVER, THE PATIENT DID EXPERIENCE A LONGER STAY FOR IV ANTIBIOTICS, PAIN MEDICATION AND IMAGING STUDIES THAT REVEALED FREE AIR IN THE ABDOMEN. THE PATIENT HAD A FOLLOW-UP VISIT WITH THE DOCTOR ON (B)(6) 2017 AND THE PATIENT IS DOING WELL. THE USER FACILITY REPORTED IT WAS A DIFFICULT PROCEDURE DUE TO RESTRICTED MOBILITY INSIDE THE PATIENT¿S COLON AND THEY ARE UNSURE WHICH DEVICE CAUSED OR CONTRIBUTED TO THE PERFORATION. 1OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861166 ENDOSCOPIC CO2 REGULATION UNIT ENDOSCOPIC CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UCR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other