MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL

Model Number WA29048A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported, the ureteroscope, 6,4/7,8 fr.X 430 mm, 7°, straight ocular angle, 4,2 fr.Channel had a loose insertion tube.The issue occurred during reprocessing.There were no reports of patient harm.

• Brand Name: URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 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: 18864677
• MDR Text Key: 337191506
• Report Number: 9610773-2024-00651
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761062510
• UDI-Public: 04042761062510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2024

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: WA29048A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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