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

Model Number	OTV-S7H-NA-10E
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing did not reproduce the report of no image from the device.Service found the cable was damaged due to physical stress, there was an air/water leak, the video connector was damaged, and the image was noisy due to deterioration of the cable but the subject could be recognized.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported there was no image from the subject device.There was no effect on a patient due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and customer follow-up.B5: updated with information received from the customer: a review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 11 years, since the subject device was manufactured.Based on the results of the investigation, the noisy image may have occurred, from a faulty cable.Which, led to a temporary communication failure.The specific root cause could not be determined at this time.The following information is stated, in the instructions for use, which may have prevented the event: "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.
Event or Problem Description
Customer confirmed, the event occurred, prior to an endoscopic sinus surgery (ess).The procedure was completed using another camera.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15237428
• Report Number: 3002808148-2022-01072
• Device Sequence Number: 6293434
• Product Code: GCJ
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043275
• 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): 09/12/2022

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-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2010
• 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