MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 5 MM, 30°, NTSC, AUTOCLAVABLE, SHORT; RIGID VIDEO LAPAROSCOPE

Model Number	WA50023S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that, during preparation for use, the rigid videoscope displayed no picture when plugged in.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h2, h3, h4, h6, h11.The device was returned to olympus for inspection and the reported failure was confirmed due to degradation.Based on the results of the investigation, the most probable cause of the complaint is component failure.However, a definitive root cause could not be identified.In addition, the following reportable malfunctions were identified during the device evaluation: crack on video connector, debris under distal cover glass, and fiber breakage.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that, during preparation for use, the rigid videoscope displayed no picture when plugged in.There were no reports of patient harm.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 5 MM, 30°, NTSC, AUTOCLAVABLE, SHORT
• 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, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19537339
• Report Number: 9610773-2024-31126
• Device Sequence Number: 18245760
• Product Code: HET
• UDI-Device Identifier: 04042761066709
• UDI-Public: 04042761066709
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K955456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: Health Professional
• Device Model Number: WA50023S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2010
• 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