MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 4 MM, 30°; RIGID SCOPE

Model Number	WA4KS430
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A manufacturing and quality control review was performed for the affected serial/lot number without showing any non-conformities or deviations regarding the described issues.The customer reports a broken optic.During inspection, the service department identifies the issues: the outer tube is deformed.Parts inside the optical system are damaged.The information provided by the service department is evaluated as plausible.The identified fault patterns are most likely attributable to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the telescope "ultra", 4 mm, 30° has broken optic.There was no report of patient harm or user injury associated with this event.

• Brand Name: TELESCOPE "ULTRA", 4 MM, 30°
• Common Device Name: RIGID SCOPE
• 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: 16826311
• Report Number: 9610773-2023-01162
• Device Sequence Number: 17859481
• Product Code: EOB
• UDI-Device Identifier: 04042761083041
• UDI-Public: 04042761083041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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: WA4KS430
• Device Catalogue Number: WA4KS430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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