MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 45°, AUTOCLAVABLE; RIGID SCOPE

Model Number	WA50374B
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information regarding the details of the event were provided from the customer.The device history records for the affected serial number was reviewed, without showing any non-conformities or deviations regarding the described issue.The referenced device was returned for evaluation and the customer reported problem was confirmed.The eyepiece was found damaged.The evaluation also noted, the rigid outer tube has deformation/bent, the image defects due to particles inside the optical lens system, and deterioration of the light guide fiber bundle at the distal end.The investigation is still in progress.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects.Check the function of all devices.And have alternate equipment prior to use.
Event or Problem Description
The customer reported, during inspection before use.The autoclavable telescope was found to have exterior damage (crack).No death or injury and no impact to patient or other has been reported.
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, it is likely that the event occurred due to user error, improper handling and application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 5.4 MM, 45°, AUTOCLAVABLE
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16924970
• Report Number: 9610773-2023-01314
• Device Sequence Number: 12496298
• Product Code: GCJ
• UDI-Device Identifier: 04042761029759
• UDI-Public: 04042761029759
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: WA50374B
• Device Catalogue Number: WA50374B
• Device Lot Number: 411235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2004
• 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