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

Model Number	OTV-S7H-1D
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation 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 that the subject device had a poor image quality.The issue was found during reprocessing for a therapeutic procedure.The procedure was completed with the same device and there were no reports of patient harm.
Event or Problem Description
It was reported that the subject device had a poor image quality.The issue was found during reprocessing for a therapeutic procedure.The procedure was completed with the same device and 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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported failure was not reproduced.However, device evaluation found the following: corrosion of electrical contacts, corrosion of adapter mounts and cable damage.A definitive root cause of the reported event could not be conclusively identified.As per ifu (instruction for use): do not clean, disinfect, sterilize, or store this product together with tweezers, forceps, scalpels, etc.There is a risk that the camera cable may become punctured, causing water leakage and damaging the electrical circuits inside the product.Be careful not to damage the camera cable with sharp objects.- do not drop or bump the product.Water leakage may damage the internal electrical circuits.Connect the video connector to the otv-s7v when it is completely dry, including the electrical contact points.If it is wet, it may malfunction.If the camera cable is coiled, do not pull it forcibly, but gradually straighten it out.There is a risk of the camera cable breaking.Do not apply excessive bending, pulling, twisting or crushing to the camera cable.There is a risk of the camera cable breaking.When wiping the outer surface of the camera cable, do not squeeze the cable too hard.The camera cable may break.When using the endoscope, hold the camera head and not the camera cable.The camera cable may break.Do not use a pen or similar object to hold the camera cable in place.The camera cable may break.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 20278876
• Report Number: 3002808148-2024-36583
• Device Sequence Number: 12698344
• Product Code: GCJ
• UDI-Device Identifier: 04953170141645
• UDI-Public: 04953170141645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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-1D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2010
• 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