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

Model Number	OTV-S7PROH-HD-12Q
Medical Device Problem Codes	No Display/Image (1183); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The evaluation confirmed the user report of "no image" due to a faulty charged coupled device unit.Kinks and cuts were also found in the cable.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Event or Problem Description
It was reported that during preparation for use for a diagnostic procedure, the user could not get an image with the hd autoclavable camera head.The customer reported no other devices were involved and there was no delay in the procedure.The procedure was completed with the same device.As reported, there was no consequence or impact to the patient due to this occurrence.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 likely the event was caused by unexpected stress on the camera head due to the user's handling, resulting in the failure of the charged coupled device, which resulted in the absence of images.The instructions for use have the following statement which can prevent the event: "do not drop the camera head or allow it to strike other objects.Strong impacts could damage the electrical circuits inside the camera head.".

• 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
• MDR Report Key: 11307452
• Report Number: 8010047-2021-02491
• Device Sequence Number: 13744783
• Product Code: GCJ
• UDI-Device Identifier: 04953170228865
• UDI-Public: 04953170228865
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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-12Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1