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

Model Number CH-S190-08-LB

Device Problems Display or Visual Feedback Problem (1184); Connection Problem (2900)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.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 is slow, the endoscope is disconnected and there is a rotation problems.There were no reports of patient harm.

• Brand Name: HD CAMERA HEAD
• Type of Device: AUTOCLAVABLE 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: 18984686
• MDR Text Key: 338765983
• Report Number: 3002808148-2024-31689
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170336669
• UDI-Public: 04953170336669
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102059
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH-S190-08-LB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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