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

Model Number	UCR
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to the olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that the reported phenomenon was attributed to the accidental failure of the internal component of the subject device.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during preparation for use of the subject device, the failure of insufflation co2 occurred intermittently.Olympus (b)(4) checked the subject device and found that the reported phenomenon could not duplicated and the foreign matter had entered the gas tube due to the damage of the internal component.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Initially, we determined that the event was mdr reportable due to a backflow of liquid from the water container into the unit co2 regulator (ucr), in which case we determined that it was a potential adverse event because of the risk for infection.Upon further investigation, it was found that liquid does not flow back into the ucr from the water container unless multiple situations occur simultaneously.There are no reports of situations occurring for this complaint.In addition, a component analysis was performed on the water droplet traces in the tube of the ucr at a similar complaint.The results of this component analysis detected silica and others that appeared to be derived from tap water, but no component that appeared to be body fluids were detected.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Common Device Name: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10683063
• Report Number: 8010047-2020-07726
• Device Sequence Number: 571816
• Product Code: HIF
• UDI-Device Identifier: 04953170239748
• UDI-Public: 04953170239748
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: UCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown