MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE; RIGID SCOPE

Model Number WA50372B

Device Problems Break (1069); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

The evaluation identified the eyepiece component was found broken off.Also, the customer¿s reported problem was confirmed, internal lens broken with debris particles visible in the eyepiece (non-reportable).The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The device was manufactured according to valid instructions and met all specifications.The device manufacturing date could not be determined; the scope was sold on june 1, 2004.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The customer autoclavable rigid telescope was returned to the olympus service center for evaluation of a reported ¿crack in the lens barrel¿.The customer reported problem was found at an unspecified event.During the evaluation, the eyepiece component was found broken off.No death or injury and no impact to patient or other has been reported to olympus.This report is being submitted to capture the broken off eyepiece component.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).In addition to the reported event it was also discovered that the ring on the light guide connector was missing, which is also a reportable malfunction.Based on the results of the investigation, the root cause could not be determined.It is likely the reported events occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE
• Type of Device: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16777569
• MDR Text Key: 313725742
• Report Number: 9610773-2023-01081
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761029599
• UDI-Public: 04042761029599
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K923982
• 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: 07/24/2023

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: WA50372B
• Device Catalogue Number: WA50372B
• Device Lot Number: 403672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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