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

Model Number	UPD-3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The field service coordinator on behalf of the customer reported, the endoscope position detecting unit was not working during a colonoscopy due to which the procedure had to be cancelled.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
The investigation is ongoing.Follow up with the user facility is currently being performed to obtain additional information regarding the event.A supplemental will be submitted on completion of investigation or if any additional information is available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer¿s investigation, an olympus field service engineer who inspected the subject device on-site found that there was no problem with the scope guide; however, the cable was defective and needed to be replaced.A root cause for the cable failure could not be determined.

• 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: 15735269
• Report Number: 3002808148-2022-03841
• Device Sequence Number: 2907699
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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?: Yes
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE.
• Patient Sex: Unknown