MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO-OPTIK "ENDOEYE 3D", 30°; VIDEO TELESCOPE OPTIC ENDOEYE

Model Number WA50082A

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The reported issue was confirmed.Visual inspection was performed found that the internal lens at the tip of the insertion tube was damaged.Due to this damage, the resolution of a part of the output image was remarkably reduced.It was noted during inspection that only the lens under the cover glass was damaged, the cover glass itself was not damaged.There were no traces indicating that the tip of the insertion tube had received an impact.Service repair noted that likely, the damage/failure observed was a result of the stress in the lens or its surroundings being released by the pressure during sterilization.Investigation however is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during inspection before use, it was observed that the tip lens was damaged inside (the cover glass was normal).The device was replaced and the intended planned procedure was completed using a similar device.There was no patient involvement on this reported event.No ham was reported, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to g2 and h4.Please see updates to g2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the damaged internal lens at the tip of the insertion tube in the charged coupled device unit was unable to be identified.However, a probable cause of the event is external force due to user error.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO-OPTIK "ENDOEYE 3D", 30°
• Type of Device: VIDEO TELESCOPE OPTIC ENDOEYE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16607653
• MDR Text Key: 312308160
• Report Number: 9610773-2023-00863
• Device Sequence Number: 1
• Product Code: GCM
• UDI-Device Identifier: 04042761083492
• UDI-Public: 04042761083492
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50082A
• Device Catalogue Number: WA50082A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• 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