MAUDE Adverse Event Report: OLYMPUS OLYMPUS URETEROSCOPE

Model Number P6R

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  Injury  

Event Description

After a complex ureteroscopy with laser lithotripsy, the flexible olympus ureteroscope (item #urf-p6r/ (b)(4)) was unable to be removed from the pt by the urologist.The urologist cut the scope and 18.5" of it still remains in the pt.Pt admitted to the hospital to await occurrence of passive dilation to enable removal.

• Brand Name: OLYMPUS URETEROSCOPE
• Type of Device: OLYMPUS URETEROSCOPE
• Manufacturer (Section D): OLYMPUS; southborough MA 01772
• MDR Report Key: 7124259
• MDR Text Key: 95175615
• Report Number: MW5074007
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P6R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2017
• 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: 59 YR
• Patient Weight: 160