MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 5.4 MM, 0°

Model Number WA4KL500

Device Problem Break (1069)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported, the telescope "ultra", 5.4 mm, 0° had a broken lens.The issue occurred during preparation for use.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: TELESCOPE "ULTRA", 5.4 MM, 0°
• Type of Device: TELESCOPE "ULTRA", 5.4 MM, 0°
• 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: 18977344
• MDR Text Key: 339259316
• Report Number: 9610773-2024-00855
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082877
• UDI-Public: 04042761082877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA4KL500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• 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