MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL

Model Number WA2UR11A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.There was an additional finding of scratch marks were visible inside the working channel near the distal end.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that the ureteroscope 6.7/8.4 fr.X 430 mm, 5°, angled ocular, 4.2 fr.Channel tip looked displaced.The event occurred during a therapeutic lower ureteric stone procedure.The procedure was completed with a similar device.There was no patient harm associated with the event.

• Brand Name: URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18354279
• MDR Text Key: 330934687
• Report Number: 9610773-2023-03684
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761086387
• UDI-Public: 04042761086387
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K200369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023

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: WA2UR11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• 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