MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE; AUTOCLAVABLE RIGID TELESCOPE

Model Number	WA96200A
Medical Device Problem Codes	Break (1069); 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
Olympus (omsc) was informed via repair request that the customer autoclavable rigid telescope has tip damage and ¿detachment of light guide connector¿.The customer reported problem was found at an unspecified event.No death or injury and no impact to patient or other has been reported to olympus.This report is being submitted to capture the broken off component defect.
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection was able to confirm/reproduce the customer¿s reported issue, broken/damaged tip and light guide connector detached from the base.The cause of the reported event is unknown.However, the investigation is still in progress.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 could not be determined.It is likely the reported event occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: AUTOCLAVABLE RIGID TELESCOPE
• 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: 16225465
• Report Number: 9610773-2023-00319
• Device Sequence Number: 5350948
• Product Code: EOB
• UDI-Device Identifier: 04042761070027
• UDI-Public: 04042761070027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944072
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: WA96200A
• Device Catalogue Number: WA96200A
• Device Lot Number: 706351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2015
• 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