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

Model Number	OTV-S7H-1NA-12Q
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the subject device had lines appearing horizontally in the picture, when they moved the connecting cable too much.The event occurred, during an unspecified procedure.That was completed using the same device.There were no reports of patient harm.
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted, when the investigation is completed or if additional information becomes available.

• 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: 20557352
• Report Number: 3002808148-2024-37502
• Device Sequence Number: 15669984
• Product Code: GCJ
• UDI-Device Identifier: 04953170141836
• UDI-Public: 04953170141836
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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-12Q
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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