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

Model Number	OTV-S7H-NA
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 subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported image loss could not be confirmed or reproduced.However, service found the electrical contacts of the video connector were corroded.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause was not able to be determined, since the customer's report could not be duplicated.Per the legal manufacturer, the corrosion on the electrical contacts of the video connector has no potential to cause or contribute to death or serious injury if the malfunction was to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The user facility reported that when preparing the subject device for use during an unspecified procedure, there was no image due to a "sandstorm" on the display.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported event.However, no additional information was provided.

• Brand Name: 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: 14164621
• Report Number: 8010047-2022-06745
• Device Sequence Number: 4988361
• Product Code: FET
• UDI-Device Identifier: 04953170141744
• UDI-Public: 04953170141744
• 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: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2013
• 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