MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 0°, WITH TROCAR TUBE CONNECTOR; ULTRA TELESCOPE

Model Number	WA4KA400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection found a reflection on the image.Minor dents on the distal end edge and minor scratches on the gold plating at the distal area.However, the customer reported ¿broken during procedure¿ could not be confirmed.Olympus requested additional details regarding the reported event and is pending.The investigation is ongoing.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
Olympus was informed by the clinical engineering supervisor that the customer ultra rigid telescope was ¿broken during surgery¿.No death, injury or harm has been reported to olympus.
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, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE ¿ULTRA¿, 4 MM, 0°, WITH TROCAR TUBE CONNECTOR
• Common Device Name: ULTRA 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: 15965448
• Report Number: 9610773-2022-00631
• Device Sequence Number: 5574408
• Product Code: HRX
• UDI-Device Identifier: 04042761083003
• UDI-Public: 04042761083003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: WA4KA400
• Device Catalogue Number: WA4KA400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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