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

Model Number	OTV-S7H-NA-12E
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 camera head had an image distortion.No patient harm or injury was reported.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found flooding in the main unit¿s image capture and camera cable.Additionally, there was corrosion on the loose scope mount.Based on the results of the investigation, it is likely that the following led to the malfunction: flooding of the main unit image capture and camera cable indicates that the internal ccd may have failed.Therefore, it is assumed that normal communication was not possible, resulting in image distortion.Corrosion was also noted on the scope mount.A device history review: 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.Instructions for use (ifu): the following statement is found in the "warnings" section in the "instructions for use" section of the instruction manual: there are no abnormalities in endoscopic images or functions.If an abnormality occurs in the endoscopic image or function and returns to normal spontaneously, the device may have already malfunctioned.If you continue to use the device as it is, the abnormality may occur again, and the device may not return to normal.In this case, discontinue use immediately and slowly pull the endoscope out of the patient.Continued use of such an instrument may injure the patient or cause bleeding or perforation.The following statement is found in the "warning" section of the instruction manual "for safe use_endoscopic image disappearance and freezing.Do not bump or drop the product.Do not bump or drop the product, as water leakage may cause damage to the product's internal electrical circuits.The following description is found in the instruction manual "preparation and inspection of camera head".Check that there is no looseness or rattling of the free lock lever when the free lock lever is lightly held and lightly rotated counterclockwise.Check that there is no looseness or rattling in the scope mount when the scope mount is operated.Olympus will continue to monitor the field performance of 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18906220
• Report Number: 3002808148-2024-31435
• Device Sequence Number: 15766880
• Product Code: FET
• UDI-Device Identifier: 04953170141867
• UDI-Public: 04953170141867
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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-NA-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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