MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HD AUTOCLAVABLE CAMERA HEAD

Model Number	OTV-S7PROH-HD-10Q
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was noted that the cable was punctured, and therefore the unit failed the leak test.It was also noted that the coupler had a rigid piece of scope stuck inside that could not be removed.If additional information becomes available following the device evaluation, a supplemental report will be filed.
Event or Problem Description
The customer reported that his olympus hd autoclavable camera head was not producing an image during use.Additional details relating to the patient and the event have been requested, but are unknown.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible that water got inside the device from the hole on the cable, and this deteriorated the cable temporarily and caused communication failure.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿never reprocess, or store this camera head with sharp-tipped instruments (tweezers, forceps, knives, etc.).This could scratch or tear holes in the camera cable, which could allow water to penetrate and damage electrical circuits inside the camera head.¿ olympus will continue to monitor field performance for this device.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Common Device Name: CAMERA HEAD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13477059
• Report Number: 8010047-2022-02541
• Device Sequence Number: 14793421
• Product Code: FET
• UDI-Device Identifier: 04953170252945
• UDI-Public: 04953170252945
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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-S7PROH-HD-10Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2008
• 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