MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; RIGID VIDEO LAPAROSCOPE

Model Number	WA50011A
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
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 a laparoscopy procedure, the subject device image was in and out intermittently.The procedure was completed utilizing a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for evaluation.And the customer¿s allegation was unable to be confirmed.In addition, the following reportable malfunctions were identified, during the device evaluation: a break in the fiber(s), the device failed to be cleaned adequately, dirt observed on the unit, dents on the distal edge and cracks on the cover glass.Based on the results of the investigation, the most probable cause of the complaint was traced to component failure.A review of the device history record found no deviations, that could have caused or contributed to the issue.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported, that during preparation for a laparoscopy procedure.The subject device image was in and out intermittently.The procedure was completed utilizing a similar device.There were no reports of patient harm.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Common Device Name: RIGID VIDEO LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; 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: 19371768
• Report Number: 9610773-2024-30642
• Device Sequence Number: 15375724
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: WA50011A
• Device Lot Number: 607263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2009
• 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