MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE

Model Number WA53000A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported that his olympus autoclavable telescope had broken components.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event (specifically the broken light-guide connector and damaged optical system) was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 16 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to excessive force/pressure or shock applied.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17816684
• MDR Text Key: 324239472
• Report Number: 9610773-2023-02711
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052757
• UDI-Public: 04042761052757
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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: WA53000A
• Device Lot Number: 537219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2007
• 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