MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE; HW70942

Model Number	A70942A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rigid scope had a missing lens.The event occurred during inspection for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The following fields were updated: d8, h3, h4, h6.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, it is likely the following led to the malfunction: a component failure of eyepiece cover glass and internal lens.The cause of failure of eyepiece cover glass and internal lens could not be determined.The event can be detected/prevented by following the instructions for use which state: chapter 2 safety information", " chapter 5 preparation¿.There is no indication that this device was not used in accordance with the ifu/labeling.Event1 lens missing (adhesion on lens).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 eyepiece cover glass and internal lens.Chapter 5.2 inspection: general inspection, make sure that the product has: no dents, cracks, bending, or deformations.No scratches.No corrosion.No lens damages or cover glass damages.No missing or loose parts.Check all markings on the product for clear visibility.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
• Common Device Name: HW70942
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21410763
• Report Number: 9610773-2025-01124
• Device Sequence Number: 18477979
• Product Code: HRX
• UDI-Device Identifier: 04042761010559
• UDI-Public: 04042761010559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951354
• 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): 06/25/2025

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: A70942A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2014
• 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