MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

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

Patient Problem Abdominal Pain (1685)

Event Type  malfunction  

Event Description

The customer reports during an unspecified procedure using a co2 regulator, the patient experienced abdominal discomfort.The user was concerned this was due to a malfunction of the device and requested the device be evaluated by olympus.The device was returned to olympus and evaluated.The user's report of device malfunction was not confirmed.The device passed inspection and functioned as designed.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the suspect device: olympus received one endoscopic co2 regulation unit model ucr, serial# (b)(4).Visual inspection as received condition found no abnormalities on the appearance.The interior components appeared to be intact and clean.The timer is in ¿short¿ position, and the gas source selection is in ¿cylinder¿ position.To check for functionality, the device was connected to the test co2 gas cylinder via a regulator.The device passed all the implemented inspection items, and the measurable inspection results are within the specification.Based on the evaluation findings, the reported complaint of device malfunction was not confirmed.The device passed inspection and functioned as designed.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, there was no device defect found.Therefore, the root cause of the event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15447845
• MDR Text Key: 306407381
• Report Number: 3002808148-2022-02161
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170239113
• UDI-Public: 04953170239113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1