MAUDE Adverse Event Report: MOR GU OLYMPUS URETEROSCOPE URF P6R-2402235; URETEROSCOPE AND ACCESSORIES, FLEXIBLE / RIGID

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2018

Event Type  Injury  

Event Description

Flexible ureteroscope lodged in mid ureter, delayed removal.Olympus.

• Brand Name: MOR GU OLYMPUS URETEROSCOPE URF P6R-2402235
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
• MDR Report Key: 8197328
• MDR Text Key: 131839799
• Report Number: MW5082601
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 95