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

Model Number OTV-S7H-1D

Device Problem Poor Quality Image (1408)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6) hospital.The device evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

It was reported, the camera head had an abnormal image.The issue occurred during cleaning and disinfecting.The diagnostic hysteroscopy procedure was completed with another device and an optical tube.The optical tube had been replaced alternately and the fault was confirmed to be in the camera.There was a surgical delay, however, there was no report of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.The image function was abnormal due to the cable failure.Additionally, loosening of adapter was noted.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

Event Description

It was reported, the camera head had an abnormal image.The issue occurred during cleaning and disinfecting.The diagnostic hysteroscopy procedure was completed with another device and an optical tube.The optical tube had been replaced alternately and the fault was confirmed to be in the camera.There was a surgical delay, however, there was no report of patient harm.

• Brand Name: 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19059922
• MDR Text Key: 340458853
• Report Number: 3002808148-2024-32012
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170141645
• UDI-Public: 04953170141645
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Health Professional
• Device Model Number: OTV-S7H-1D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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
• Treatment: OPTICAL TUBE