MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE

Model Number WA50012A

Device Problem Break (1069)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

It was reported, the video telescope "endoeye", 10 mm, 30°, pal, hd compatible, autoclavable light guide bundle was broken.The issue occurred during a therapeutic laparoscopic procedure.The procedure was completed using the same set of equipment.There were no reports of patient harm.

Manufacturer Narrative

The device was returned, and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE
• Type of Device: VIDEO TELESCOPE
• 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: 18941530
• MDR Text Key: 339098513
• Report Number: 9610773-2024-00793
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50012A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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