MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 10 MM, 30°; RIGID SCOPE

Model Number WA4KL130

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was observed that during the device inspection, the rigid scope had not a clear picture, you can see the inside of scope.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned, and customer's allegation was confirmed.The following were found during the evaluation; sunk down system tube and debris under objective; and dry ring debris under eyepiece window glass, and not a clear picture, you can see the inside of scope the evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TELESCOPE "ULTRA", 10 MM, 30°
• Type of Device: RIGID SCOPE
• 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: 18951924
• MDR Text Key: 339107527
• Report Number: 9610773-2024-00814
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082853
• UDI-Public: 04042761082853
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA4KL130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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