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

Model Number	A70963A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.Additional findings were as follows: insertion tube had been bent but was still in a single piece and there was deformation of the outer tube without causing any damage inside the optical system.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 root cause of the event was unable to be identified; however, the event most likely occurred due to 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 "trueview ii", 2.7mm, 30°, short, autoclavable had broken into two pieces.The event occurred during sterilization.There was no patient harm associated with the event.

• Brand Name: TELESCOPE "TRUEVIEW II", 2.7MM, 30°, SHORT, AUTOCLAVABLE
• Common Device Name: ARTHROSCOPY SYSTEM
• 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: 18228899
• Report Number: 9610773-2023-03416
• Device Sequence Number: 6203055
• Product Code: HRX
• UDI-Device Identifier: 04042761010658
• UDI-Public: 04042761010658
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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): 11/29/2023

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 Lot Number: 636673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2013
• 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