MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. IR INTERFACE FOR UCES-3; COMMUNICATION CONVERTER

Model Number	MAJ-1862
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the cable from the table connection transmitter was broken.Additional information was received that the connection issue was caused by the connector.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The subject device was not sent to olympus for evaluation.Based on the results of the legal manufacturer's investigation, it is likely the reported issue was due to disconnection of the cable.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated field are h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, we surmised that a cable break occurred.But, we could not identify the cause of the cable break.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4 of the initial medwatch.The serial number should be (b)(6).The device was inspected by technician and it was exchanged the cable.Olympus will continue to monitor field performance for this device.

• Brand Name: IR INTERFACE FOR UCES-3
• Common Device Name: COMMUNICATION CONVERTER
• 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: 15213799
• Report Number: 3002808148-2022-00896
• Device Sequence Number: 4730104
• Product Code: GCJ
• UDI-Device Identifier: 04953170291579
• UDI-Public: 04953170291579
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102763
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2022

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: MAJ-1862
• 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: 02/06/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 08/31/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/31/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2010
• 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