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

Model Number	OTV-S7H-1NA-12E
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the camera head's plug-in portion was not secure and when it was moved, the video image is effected.The issue occurred during preparation of a therapeutic laparoscopic hernia repair and was completed using a similar device.There were no reports of patient harm.A request for further clarification of the "video image effected" is in progress.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the approved final investigation.Since, the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since the device malfunction was not confirmed, during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported, the camera head's plug-in portion was not secure.And when it was moved, the video image is effected.The issue occurred, during preparation of a therapeutic laparoscopic hernia repair.And was completed using a similar device.There were no reports of patient harm.A request for further clarification of the "video image effected" is in progress.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19181264
• Report Number: 3002808148-2024-32430
• Device Sequence Number: 7298191
• Product Code: GCJ
• UDI-Device Identifier: 04953170141898
• UDI-Public: 04953170141898
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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-S7H-1NA-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Distributor Facility Aware Date: 05/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2004
• 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