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

Model Number	A70963A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found that the internal lens of the eyepiece is chipped which caused a bad image.The device evaluation also found that distal end was dented.The root cause for the reported issue cannot be definitely determined.Based on the inspection findings the most likely cause is use of excessive force by the customer.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.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus, the lens of the scope was broken.There were no reports of patient harm.

• Brand Name: TELESCOPE "TRUEVIEW II", 2.7MM, 30°, SHORT, AUTOCLAVABLE
• Common Device Name: ARTHROSCOPES
• 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: 17368523
• Report Number: 9610773-2023-01933
• Device Sequence Number: 12514806
• Product Code: HRX
• UDI-Device Identifier: 04042761010658
• UDI-Public: 04042761010658
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: A70963A
• Device Catalogue Number: A70963A
• Device Lot Number: 667656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2014
• 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