MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE; Endoscope, accessories, narrow band spectrum

Model Number WA50012A

Device Problem Break (1069)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

It was reported that during cleaning and disinfection of the subject device, the button #1 and the lightguide hose were found broken resulted in blurred and distorted screen.There was no report of patient harm.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: 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: 19188993
• MDR Text Key: 341460489
• Report Number: 9610773-2024-30176
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50012A
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CV-190