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

Model Number OTV-S7H-NA-10E

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The reported issue (part of image not displayed) was confirmed during testing; this was determined caused by a defective coupler unit.In addition to the partial loss of image, the following issues were identified: the coupler unit was corroded; one of the washer rings was deformed and dirty; a portion of the camera head could not be fully fixed back into place; screws can't be fixed with proper torque into the switch button stage, remote button 2 was non-functional; the connector cable had a pinhole; the remote buttons had sustained fluid ingression; and the ac plate was discolored.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.

Event Description

The customer reported the olympus autoclavable camera head caused the displayed image to partially disappear.The issue was identified during reprocessing.No adverse effects to patient were reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon, "the image is cropped due to a defective coupler unit¿, was confirmed.Therefore, it was determined that the reportable phenomenon, "the image is not displayed at full", occurred due to a defective coupler unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

• Brand Name: 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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17083939
• MDR Text Key: 316797483
• Report Number: 3002808148-2023-05713
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K043275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTV-S7H-NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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