MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 70°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; RIGID SCOPE

Model Number	WA96205A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device evaluation found a broken light guide post.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, the cause of the reported issue is most likely due to user error, improper handling as well as the application of excessive force.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus, the telescope, 4 mm, 70°, connector for light guide on bottom, autoclavable had a broken light guide post.The issue was found during inspection for use.The intended procedure was endoscopic sinus surgery.The procedure was completed with a similar device.There were no reports of patient harm.

• Brand Name: TELESCOPE, 4 MM, 70°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: RIGID 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16503995
• Report Number: 9610773-2023-00684
• Device Sequence Number: 3352003
• Product Code: EOB
• UDI-Device Identifier: 04042761070072
• UDI-Public: 04042761070072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: WA96205A
• Device Catalogue Number: WA96205A
• Device Lot Number: 684505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown