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

Model Number OTV-S7PROH-FD

Device Problem Poor Quality Image (1408)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported, the camera head fell and got damaged.Picture was not ok.The event occurred during preparation for an unspecified procedure.There were no reports of patient harm.

Manufacturer Narrative

The device evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Manufacturer Narrative

Correction is being made to submitted "b4 - date of this report" for the initial, which was not late.The correct date was 04/05/2024.The report was submitted on apr 5, 2024 at 13:27:25 edt to fda esg and then did not progress.There were no failures or acknowledgements received.The it team was notified same day.An fda esg ticket 387502 was raised with a reply on apr 10, 2024 from fda esg team stating "please resend these submissions.There was an issue on the gateway when these were sent so they were not processed." the file was resubmitted without any changes and subsequently passed receiving all three acknowledgements.Additional information: d9, h3, h4, h6 and h11: the device was inspected at the regional repair center.The device underwent a visual inspection and functional tests and passed all functional and leak tests.It was found to be within specifications; therefore, the customer allegation was not confirmed.A device history review (dhr) was completed, and no issues were identified.Service history did not indicate anything that could have led to this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the camera head fell and got damaged.Picture was not ok.The event occurred during preparation for an unspecified procedure.There were no reports of patient harm.

• 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 (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: 19169442
• MDR Text Key: 341432500
• Report Number: 3002808148-2024-31978
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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-S7PROH-FD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/03/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• 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