MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 30°, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE

Model Number	WA50373B
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rigid scope had cracked lens.The issue occurred during reprocessing.There was no patient involvement.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No new information has been provided by the customer.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.Based on historical data and the investigation, it is most likely that the reported issue was caused by components failure of the eyepiece cover glass.However, a root cause analysis could not be determined/identified.The event can be prevented by following the instructions for use which state: chapter 2.5 general warnings and cautions: warning: risk of injury to the patient and/or the user.The use of a damaged product or of a product with improper functioning may cause an electric shock, mechanical injury, infection, and/or thermal injury.Before each use, observe the instructions in the section ¿inspection¿ in this document.Do not use a damaged product or a product with improper functioning.Replace a damaged product or a product with improper functioning.Notice: risk of damage to the product.The endoscope is a precise optical device.Careless handling may damage the endoscope.Always handle the endoscope with care.Do not hold the endoscope by the distal end only.Do not bend the insertion tube.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 5.4 MM, 30°, AUTOCLAVABLE
• Common Device Name: RIGID OPTICAL LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 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: 21664260
• Report Number: 9610773-2025-02185
• Device Sequence Number: 7922439
• Product Code: GCJ
• UDI-Device Identifier: 04042761029582
• UDI-Public: 04042761029582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: WA50373B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2014
• 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