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

Model Number	OTV-S7PROH-HD-10Q
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the hd autoclavable camera head has sudden loss of image.The event occurred during preparation for use and there was no patient involvement, no harm or user injury reported due to the event.
Additional Manufacturer Narrative
This initial report includes the device history record(dhr) review , evaluation notes, and results from the legal manufacturer investigation.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.The device was returned for evaluation.Upon evaluation of the device, the reported issue of image loss was confirmed.In addition, dent connector, cable twist, cable scratches and head switch discoloration were observed.The root cause of the phenomenon was unable to be identified.However, the probable cause of the image not displaying was due to flooding of the imaging unit and cable at the head part.As a result, communication failure occurred, and the image was not displayed.It is presumed that water entered because there was a damage in the cable.As a result of checking the dhr, it was confirmed that there were no manufacturing abnormalities or variations.The instructions for use (ifu) states the following information regarding cable scratches: do not wash, disinfect, sterilize, or store this product with tweezers, forceps, scalpels, etc.A hole in the camera cable may be exposed, and water leakage may destroy the electrical circuitry inside the product.Do not bump or drop this product.Water leaks can destroy the electrical circuitry inside the product olympus will continue to monitor complaints 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: 13475085
• Report Number: 8010047-2022-02518
• Device Sequence Number: 3871703
• Product Code: FET
• UDI-Device Identifier: 04953170252945
• UDI-Public: 04953170252945
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 01/10/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2008
• 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