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

Model Number	OTV-S7PROH-HD-12E
Medical Device Problem Codes	Crack (1135); Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.A definitive cause of the customer's experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the tip of the connector is cracked.The user's report of blurry image is confirmed and is due to a faulty charging cord.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported an hd autoclavable camera head was found to have a blurry image.There was no patient impact related 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 head due to the user's handling, resulting in the failure of the charge-coupled device (ccd) unit, 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: 11285107
• Report Number: 8010047-2021-02277
• Device Sequence Number: 17104428
• Product Code: FET
• UDI-Device Identifier: 04953170179822
• UDI-Public: 04953170179822
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1