MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; SINUSCOPE

Model Number	WA96200A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the customers allegation was confirmed.It was also noted that the outer cylinder was bent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus representative reported that the lens of the telescope was damaged.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s final investigation.The review of the device history record did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The investigation determined the most likely cause of the failure to be improper handling and application of excessive force.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: SINUSCOPE
• 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: 16058358
• Report Number: 9610773-2022-00754
• Device Sequence Number: 14686584
• Product Code: EOB
• UDI-Device Identifier: 04042761070027
• UDI-Public: 04042761070027
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: WA96200A
• Device Catalogue Number: WA96200A
• Device Lot Number: 777151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2018
• 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