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

Model Number	CH-S190-XZ-Q
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the quick lock part of the hd autoclavable camera head was damaged.Inspection and testing of the returned device found cable failure.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation of damaged quick lock part was confirmed.The device evaluation found the image was not visible due to cable failure.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon was reproduced.It was determined that an image was disturbed because communication failure occurred due to a faulty cable.The cause of the faulty cable could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿do not coil the camera cable with a diameter of less than 20 cm.The camera cable may be damaged.Never excessively pull the camera cable but straighten it gradually when it is coiled.The camera cable could be damaged.Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.The camera cable could be damaged.Do not use excessive force when wiping the external surfaces of the camera cable.The camera cable could be damaged.Never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope.The camera cable could be damaged.Never use a clamp or forceps to attach the camera cable to another object.The camera cable could be damaged." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17167766
• Report Number: 3002808148-2023-06197
• Device Sequence Number: 17596974
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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
• Date Returned to Manufacturer: 05/25/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• 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