MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 2.7 MM, 30°, AUTOCLAVABLE; TELESCOPE AUTOCLAVABLE

Model Number	A70961A
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 subject device was received and evaluated.Device evaluation found the reported issue was confirmed.Evaluation found the outer tube was snapped in half, device was returned without inner, outer light guide (lg) adapter.Object window was inspected and a broken meniscus and dent on distal edge was observed.In addition, no image was observed due to outer tube snapped in half.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Company representative reported the device insertion tube was snapped in half, a service repair order was requested.There was no patient involvement on this reported event.No harm was reported, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 definitive root cause of the snapped insertion tube could not be determined.It is possible that the damage was caused by user error, improper handling, or the application of excessive force.Additional information about the event was requested, but was not received.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 2.7 MM, 30°, AUTOCLAVABLE
• Common Device Name: TELESCOPE AUTOCLAVABLE
• 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: 16617048
• Report Number: 9610773-2023-00881
• Device Sequence Number: 20370731
• Product Code: HRX
• UDI-Device Identifier: 04042761010634
• UDI-Public: 04042761010634
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: Health Professional
• Device Model Number: A70961A
• Device Catalogue Number: A70961A
• Device Lot Number: 758950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• 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