MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number	WA50011A
Medical Device Problem Code	Poor Quality Image (1408)
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 the rigid video scope displayed a blurry image.There was no patient involvement.Event description-scope is blurry.Cutover y/n-y.When during procedure did event occur?-unknown ^09.
Event or Problem Description
It was reported the rigid video scope displayed a blurry image.There was no patient involvement.Event description-scope is blurry cutover y/n-y when during procedure did event occur?-unknown ^09.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Please see also section h2, h3, h4, h6 and h11 for updates.The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition, new damages/defects were observed: debris and moisture found under distal cover glass, and dents on distal edge.Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure, which is expected or random component failure without any design or manufacturing issue a device history record- dhr review was conducted, and no issues were identified.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Common Device Name: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• 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: 19133527
• Report Number: 9610773-2024-30063
• Device Sequence Number: 17323924
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2008
• 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