MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH URETEROSCOPE

Model Number URF P6R

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/11/2019

Event Type  Injury  

Event Description

Flexible ureteroscope became lodged in pt and could not be removed at end of procedure.Fda safety report id# (b)(4).

• Brand Name: URETEROSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH
• MDR Report Key: 9104091
• MDR Text Key: 159849945
• Report Number: MW5089945
• 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: 09/18/2019

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: Lay User/Patient
• Device Model Number: URF P6R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 111