MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO SCOPE

Model Number WA50011A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device evaluation found damaged cover glass, and a lens crack on the light guide connector.Furthermore, the following additional issues (non-reportable) were identified during inspection: cable scratches, bad image due to objective lens crack and dented outer tube.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer returned the video telescope "endoeye", to olympus repair center for evaluation of a reported damaged cable.During the evaluation, damaged cover glass, and a broken light guide bundle were detected.This report is being submitted to capture the damaged cover glass, and a broken light guide bundle defects found during the repair evaluation.There were no reports of patient harm.

Manufacturer Narrative

Based on the results of the investigation, severe damage to the cover glass on the light guide connector of the cable unit is attributed to improper handling, user error.However, a definitive root cause cannot be established.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: RIGID VIDEO SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17193889
• MDR Text Key: 318190428
• Report Number: 9610773-2023-01725
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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: WA50011A
• Device Catalogue Number: WA50011A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2012
• 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