MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HD AUTOCLAVABLE CAMERA HEAD

Model Number	OTV-S7PROH-HD-12Q
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned by the customer to date.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
It was reported, the camera cord was not working.The device was not staying connected and the port was loose.The issue occurred at the beginning of a shoulder arthroscopy procedure and was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The evaluation also identified a slice on the cable and no image due to a faulty charge-coupled device.A definitive root cause for all evaluation findings was unable to be determined.A device history review of the current product was conducted, and no problems were found.Olympus will continue to monitor the field performance of this device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.
Event or Problem Description
It was reported, the camera cord was not working.The device was not staying connected and the port was loose.The issue occurred at the beginning of a shoulder arthroscopy procedure and was completed using a similar device.There were no reports of patient harm.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Common Device Name: CAMERA HEAD
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18933970
• Report Number: 3002808148-2024-31508
• Device Sequence Number: 4580497
• Product Code: GCJ
• UDI-Device Identifier: 04953170228865
• UDI-Public: 04953170228865
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: OTV-S7PROH-HD-12Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2009
• 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