MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HD AUTOCLAVABLE CAMERA HEAD

Model Number OTV-S7PROH-HD-12E

Device Problems No Display/Image (1183); Moisture Damage (1405); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No additional information was available.(phone/email): additional information was requested.A supplemental report will be submitted should additional information be made available.The device was evaluated, and the reported issue was confirmed.The cable was twisted.Due to the cable failure, the image had noise.The electrical contact on the connector had a dent, wear, and corrosion.The switch had discoloration, and the scope mount was loose.The investigation was ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The distributor reported on behalf of the customer, during a procedure, the screen suddenly became dark while using the high-definition autoclavable camera head.No patient injury or procedure impact reported.During the evaluation of the device, it was noted there was a sudden loss of image due to board failure (short-circuit) due to water immersion.This report is to capture the reportable malfunction of a sudden loss of image due to board failure (short-circuit) due to water immersion noted at estimation.

Manufacturer Narrative

This supplemental report is being submitted to provide the title, phone number, and email address for the reporter.See updated section e1.

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, the cause of the phenomenon (no image) was due to faulty cable.The root cause could not be identifed.Olympus will continue to monitor field performance for this device.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15456432
• MDR Text Key: 306323161
• Report Number: 3002808148-2022-02200
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170228834
• UDI-Public: 04953170228834
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7PROH-HD-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1