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

Model Number CH-S190-08-LB

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that when the camera head was used with the cautery unit, the camera's display would flicker when the physician fired the cautery.This issue occurred during the start of the therapeutic procedure.There was no error code observed and the procedure was completed using a similar device without delay.There were no reports of patient harm.

Manufacturer Narrative

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

• 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: 18984310
• MDR Text Key: 338755258
• Report Number: 3002808148-2024-31677
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170336669
• UDI-Public: 04953170336669
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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