MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO SCOPE

Model Number WA50013A

Device Problem Break (1069)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no additional malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6) hospital.

Event Description

It was reported, the rigid video scope's cover came off due to deterioration.The issue occurred during preparation for use for an unspecified procedure.The intended procedure was completed with the same device.There were no reports of patient harm or procedural delay.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and the associated h6 coding.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, it is likely that the scope cover came off due to damage from user handling.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: RIGID VIDEO SCOPE
• 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: 18789345
• MDR Text Key: 337422494
• Report Number: 9610773-2024-00546
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04042761061957
• UDI-Public: 04042761061957
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: WA50013A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2009
• 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