MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOSCOPE POSITION DETECTING UNIT

Model Number	UPD-3
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports during an unspecified procedure using an endoscopic position detecting device with a video system center, the user was unable to capture an image.There was a 45-minute delay in the procedure which left the patient in pain.The user had to capture the image manually.No additional consequences to the patient were reported as a result of this occurrence.The equipment was inspected onsite by medical engineering.Medical engineering confirmed that the scope guide had a loose connection which was resolved by the hospital¿s staff on site.The video system center had issues with the settings which has now been rectified using tech support.With that said medical engineering believe that the issue did not lie with the equipment.The equipment is not being returned to olympus for evaluation since the issues were corrected onsite.Case with patient identifier (b)(6) reports the video system center used in the procedure.Case with patient identifier (b)(6) reports the endoscopic position detecting device used in the procedure.
Additional Manufacturer Narrative
This report is being updated to report corrected information.
Additional 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 2 years since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for an evaluation, the root cause of the reported event could not be determined.However, it is likely that the following occurred: patient was left in pain due to the image issue, an issue with the processor and scope guide, and/or there was a clinically relevant delay occurred 45 minutes.This supplemental report includes a correction to d4.Udi number inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE POSITION DETECTING UNIT
• Common Device Name: ENDOSCOPE POSITION DETECTING 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: 15650453
• Report Number: 3002808148-2022-03418
• Device Sequence Number: 2428437
• Product Code: PGU
• UDI-Device Identifier: 04953170331145
• UDI-Public: 04953170331145
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K134026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2023

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: UPD-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 02/02/2023; 02/02/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 10/21/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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