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

Model Number WA50011A

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the video telescope had poor image quality.There were no reports of patient harm.

Manufacturer Narrative

E2: health professional ¿ (blank) and e3: occupation ¿ no information provided.The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 0°, NTSC, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: VIDEO TELESCOPE
• 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: 19216708
• MDR Text Key: 341636850
• Report Number: 9610773-2024-30248
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04042761061728
• UDI-Public: 04042761061728
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Model Number: WA50011A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1