MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number	WA2T43WA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.In addition to evaluation in b5, the outer tube was bent.The distal end had dents.There were minor scratches on the outer tube.The objective window had breakage fiber.There were deep scratches on the objective frame.There was severe debris under the eye piece window cover glass.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A customer reported to olympus, during reprocessing, the telescope had a cracked lens.There was no report of patient harm associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: a broken lens with blurry image.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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 determined error patterns indicate that the cause for the described issues is excessive use.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE
• Common Device Name: RIGID ENDOSCOPE 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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18507678
• Report Number: 9610773-2024-00157
• Device Sequence Number: 18108691
• Product Code: FGC
• UDI-Device Identifier: 04042761077569
• UDI-Public: 04042761077569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: WA2T43WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• 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