MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Gas/Air Leak (2946)

Patient Problem Abdominal Pain (1685)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: colonoscope: cf hq190l 2874198-171, then switched to pcf h190l 2604326-192, multiple snares (with cautery via erbe generator), injection needle, orise injection, endomark injection, clips.The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.Physical evaluation reveals: the unit was tested but the technician was unable to recreate the problem that the customer reported, however, the unit failed the gas leak test of the secondary piping due to the separator and valves units are faulty.This report will be updated at the completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported after a colonoscopy with polypectomies procedure for the indication of positive fecal immunochemical test (fit), using an endoscopic co2 regulation device and 2 different colonoscopes, the patient experienced abdominal pain, thought to be due to hyperinflation.The patient was rolled between the right and left side, instructed to pass gas, ambulated to the bathroom, and follow a liquid diet for the remainder of the day (conservative measures) the pain improved, and the patient was discharged the same day with a driver.No medical or surgical intervention was required.It was not known if the co2 regulation device malfunctioned in any way.It was tested per usual guidelines (immersed in water, no air bubbles emitted, then tested with finger lightly covering air/water button, bubbles emitted, then button fully depressed and water squirting out the side channel) everything checked out okay, and nothing seemed abnormal.

Manufacturer Narrative

This supplemental report is being submitted to correct data: d9 - date returned to manufacturer.This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The reported events were not related to a design-related defect.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the patients abdominal pain due to excessive inflation, is likely due to an influence other than the device (connected device, patient condition).

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11867078
• MDR Text Key: 268110193
• Report Number: 8010047-2021-06620
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 86