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

Model Number	OTV-S7H-NA-10E
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The reported issue (part of image not displayed) was confirmed during testing; this was determined caused by a defective coupler unit.In addition to the partial loss of image, the following issues were identified: the coupler unit was corroded; one of the washer rings was deformed and dirty; a portion of the camera head could not be fully fixed back into place; screws can't be fixed with proper torque into the switch button stage, remote button 2 was non-functional; the connector cable had a pinhole; the remote buttons had sustained fluid ingression; and the ac plate was discolored.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.
Event or Problem Description
The customer reported the olympus autoclavable camera head caused the displayed image to partially disappear.The issue was identified during reprocessing.No adverse effects to patient were reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon, "the image is cropped due to a defective coupler unit¿, was confirmed.Therefore, it was determined that the reportable phenomenon, "the image is not displayed at full", occurred due to a defective coupler unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

• Brand Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17083939
• Report Number: 3002808148-2023-05713
• Device Sequence Number: 16845473
• Product Code: IYO
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K043275
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: OTV-S7H-NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2013
• 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