MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HD CAMERA HEAD; ENDOSCOPE VIDEO CAMERA

Model Number CH-S190-08-LB

Device Problem Crack (1135)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

The customer reported to olympus during preparation for use, displayed a b30 (scope communication error) on the hd camera head.Upon inspection and testing of the customer returned device, the unit failed a leak test due to a cracked connector.This report is being submitted as a mdr based on this evaluation result.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was not confirmed.The evaluation uncovered the unit failed a leak test due to a cracked connector.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the b30 scope communication error could not be determined.It is possible that the b30 scope communication error occurred due to a faulty connector.Olympus will continue to monitor field performance for this device.

• Brand Name: HD CAMERA HEAD
• Type of Device: ENDOSCOPE VIDEO CAMERA
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14645007
• MDR Text Key: 301642037
• Report Number: 8010047-2022-09739
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170336669
• UDI-Public: 04953170336669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: CH-S190-08-LB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1