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

Model Number	CH-S190-XZ-Q
Medical Device Problem Code	No Display/Image (1183)
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 no image.There were no reports of patient harm.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation but has not yet been received.The investigation is ongoing.A supplemental report will submitted upon completion of the investigation or if additional information is provided by the user facility.
Additional Manufacturer Narrative
Updated fields: d8, d9, g3, h2, h3, h4, h6, h10 the device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation also found a broken wire in the camera cable.Based on the results of the investigation, it is likely that the following led to the malfunction: internal charge coupled device failed.A definitive root cause cannot be identified.A device history review of the current product was conducted, and no problems were found.This issue is addressed in the instructions for use (ifu): the following statement is found in the "warnings" section in the "instructions for use" section of the instruction manual.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 in the instruction manual "storage": ·when wiping the outer surface of the camera cable, do not wipe it with a cloth.When wiping the outer surface of the camera cable, do not squeeze the camera cable strongly.There is a possibility that the camera cable may break.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
This supplemental report is being submitted to provide additional information received from the customer and the legal manufacturer¿s final investigation.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Common Device Name: AUTOCLAVABLE 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: 18707912
• Report Number: 3002808148-2024-30755
• Device Sequence Number: 15580541
• Product Code: FET
• UDI-Device Identifier: 04953170310782
• UDI-Public: 04953170310782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: CH-S190-XZ-Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2012
• 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