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

Model Number UCR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abdominal Distention (2601)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Concomitant devices: colonoscope: (b)(4), multiple snares (cold and with cautery via erbe generator), injection needle, orise injection, endomark injection, clips.Physical evaluation of the complaint device reveals: visual inspection on the as is received condition of the device; observed that there are no indications of physical damage on the housing of the device.There are no missing or damaged portions on the housing as well as the rear panel.A functional test was performed on the ucr using a test co2 tank, test regulator containing two manometers and a test cylinder hose.Mq secured the connection of the test cylinder hose and the co2 gas inlet on the ucr by hand tightening it with a wrench.The test cylinder hose was then connected to the regulator and the regulator was attached to the test co2 tank with no issues.The technician opened the top cover of the ucr and visually inspected the inside verifying nothing was abnormal.The technician turned the switch option from pipeline to cylinder on the rear panel for the co2 gas inlet.The leakage of the primary piping and secondary piping were checked and mq confirmed that both primary and secondary piping have no leaks.The gas supply function was inspected and passed with no issues.The gas supply pressure test was performed using an additional manometer, flow meter and flow measuring test jigs.Mq verified with the additional manometer that when the flow is 0 l/min the gas supply pressure is 42.4 kpa which is within standard specifications as the standard is 41.5 +/- 3.5 kpa.The quantity of the gas flow was then measured with the flow measuring test jigs.The technician identified that when the thin measuring test jig was connected, the quantity of the co2 gas flow measured at 0.8 l/min which passed as the standard is 0.8 +/- 0.1 l/min.When the technician connected the thick measuring test jig was connected, the quantity of the co2 gas flow measured at 1.8 l/min which also passed as the standard is 1.9 +/- 0.2 l/min.The minimum measuring jig was attached and mq verified that the gas flow led lights up indicating the device was working properly.The technician was unable to see any indications of discrepancies as this device passed the leakage, gas supply pressure and the quantity of the gas flow tests.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported after a diagnostic colonoscopy using an endoscopic co2 regulation unit with a cf hq190l colonoscope, the patient had abdominal pain and distention (abdomen tight and tender) thought to be due to hyper-inflation.The patient required unplanned labs, computerized tomography (ct) exam and surgical consult due to these symptoms.Two hours and 15 minutes after initial distention was noted by the physician, the patient¿s pain and distention resolved, ct showed no bowel perforation.The patient discharged home with driver same day.The endoscopic co2 regulation unit 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, nothing seemed abnormal.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to d9 - date returned to manufacturer.This supplemental report is also 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 event is not design related.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the patient's complaint of abdominal pain due to excessive inflation is likely caused by an influence other than the device (connected device, patient condition) since no abnormality was found in the air supply function.

• 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: 11828488
• MDR Text Key: 250858492
• Report Number: 8010047-2021-06323
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 86