MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, STRAIGHT OCULAR, 3.7 FR. 2.6 FR. CHANNEL

Model Number WA2UR23A

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported, the ureteroscope 6.9/8.4 fr.X 430 mm, 5°, straight ocular, 3.7 fr.2.6 fr.Channel was broken and the brush could not go through the port to clean properly.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, STRAIGHT OCULAR, 3.7 FR. 2.6 FR. CHANNEL
• Type of Device: URETEROSCOPE
• 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: 18977229
• MDR Text Key: 338679043
• Report Number: 9610773-2024-00854
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761086431
• UDI-Public: 04042761086431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA2UR23A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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