MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 1.9 MM, 30°, 280 MM, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number	A4677A
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6).Added here due to character limitation in respective field.
Event or Problem Description
It was reported the rigid endoscope telescope had a visible white spot that was preventing visibility during surgery.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction: d9.Additional information: h4, h6, h11.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 reported event could have resulted from the effects of a large mechanical force due to shock, fall or collision with other equipment.However, the device was not returned for evaluation.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 1.9 MM, 30°, 280 MM, 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: 20368167
• Report Number: 9610773-2024-02420
• Device Sequence Number: 6868719
• Product Code: FJL
• UDI-Device Identifier: 04042761006392
• UDI-Public: 04042761006392
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K904940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: A4677A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• 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