MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 45°, NTSC, HD COMPATIBLE, AUTOCLAVABLE, LONG; RIGID VIDEO LAPAROSCOPE

Model Number	WA50015L
Medical Device Problem Codes	Dent in Material (2526); Scratched Material (3020)
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 and the evaluation found: deep scratches on distal edge, and dented outer tube.Based on the results of the investigation, it is likely that the following led to the malfunction: cause traced to component failure.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed that during the device evaluation, that the subject device exhibited deep scratches on distal edge and dented outer tube.There were no reports of patient involvement.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 45°, NTSC, HD COMPATIBLE, AUTOCLAVABLE, LONG
• Common Device Name: RIGID VIDEO LAPAROSCOPE
• 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: 20745465
• Report Number: 9610773-2024-33429
• Device Sequence Number: 15525571
• Product Code: NWB
• UDI-Device Identifier: 04042761062114
• UDI-Public: 04042761062114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: Other
• Device Model Number: WA50015L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2017
• 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