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

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
The customer originally returned his olympus trueview ii telescope due to unspecified optics defects.There was no patient harm reported as a result of the above event.During the device evaluation, it was discovered that the light guide connector had become detached.This report is being submitted to capture the confirmed detached light guide connector noted during the device evaluation.
Additional Manufacturer Narrative
This combined initial and supplemental report is being submitted to provide the initially reported event, as well as the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), as well as a historical trending analysis were conducted during this investigation.The device was returned and evaluated.During the evaluation, as noted in b5, the light guide connector was found detached.Additionally, the internal lens was damaged, and the unit had image failure due to a misalignment of the objective lens.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, it is believed that excessive force caused the reported failure mode.Given the condition of the returned device, investigators believe that the failures can be attributed to user error, improper handling, and an application of excessive force.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
• Common Device Name: 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17938972
• Report Number: 9610773-2023-02938
• Device Sequence Number: 20528714
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: A70942A
• Device Lot Number: 710672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2016
• 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