MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE; TELESCOPES

Model Number	WA2T400A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the telescope "oes elite", 4 mm, 0°, hd, autoclavable lens was missing.The event occurred during reprocessing.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.Additionally, there proximal bent, received without inner, outer adapters and without protector tube, there was fiber breakage; dents on the edge; and cloudy image.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the approved final investigation.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 issues is most likely, due to improper handling and the application of excessive force.Since, the reported malfunction was not confirmed, during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 0°, HD, AUTOCLAVABLE
• Common Device Name: TELESCOPES
• 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: 18424855
• Report Number: 9610773-2024-00042
• Device Sequence Number: 8014544
• Product Code: FGC
• UDI-Device Identifier: 04042761077491
• UDI-Public: 04042761077491
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: WA2T400A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2016
• 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