MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR; ANGLED OCULAR TELESCOPE

Model Number	A37025A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repair inspection confirmed/reproduced the customer¿s reported issue.The image is blurry/foggy.Additionally, the outer tube tip was found damaged.The inspection also noted the rigid outer tube is bent and there is poor/insufficient light transmission due to broken fibers at the distal tip.A review of the device history records (dhr) was performed for the affected lot number without showing any non-conformities or deviations regarding the described issues.An investigation was performed by the legal manufacturer which determined that there is no design, manufacturing, material or processing related cause for the reported event.Based on the legal manufacturer¿s investigation, the failures identified indicate user error and wear as the potential cause.Olympus will continue to monitor the occurrence rate of the reported phenomenon related to the device.
Event or Problem Description
Olympus (omsc) was informed that during an unspecified event, the customer oes angled ocular telescope was returned to the olympus repair center for a reported poor image problem.However, during the repair inspection broken optical light fibers was found due to a damaged distal tip on the outer tube.No death injury or infection and no impact to person or other was reported to olympus.This report is being submitted to capture the broken component on the outer tube.

• Brand Name: OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: ANGLED OCULAR TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16108727
• Report Number: 9610773-2023-00102
• Device Sequence Number: 19630308
• Product Code: FGA
• UDI-Device Identifier: 04042761023214
• UDI-Public: 04042761023214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: Other
• Device Model Number: A37025A
• Device Catalogue Number: A37025A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2007
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown