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

Model Number CH-S190-XZ-E

Device Problem Connection Problem (2900)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found coupler had rust.Based on the results of the investigation, it is likely that the following led to the malfunction: the most probable cause of the complaint is traced to component failure, which is expected or random component failure without any design or manufacturing issue.A device history review was completed, and no issues were identified.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported, during preparation for use the subject device rigid scope did not clip onto the camera head well, camera head's scope insertion point.The issue was found during a therapeutic laparoscopic procedure and was completed using the same device.The customer had an extra hand to hold the rigid scope in place while continuing the surgery.No surgical delay and no patient harm was reported by the customer.

• Brand Name: HD AUTOCLAVABLE 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: 19004452
• MDR Text Key: 339148696
• Report Number: 3002808148-2024-31792
• Device Sequence Number: 1
• Product Code: FET
• UDI-Device Identifier: 04953170310799
• UDI-Public: 04953170310799
• 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,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH-S190-XZ-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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: CV-190