MAUDE Adverse Event Report: OLYMPUS AMERICA OLYMPUS; FLEXIBLE URETEROSCOPE

Model Number URF TYPE P5

Device Problem Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Retained portion of ureteroscope during laser lithotripsy and ureteral stent placement.Pt underwent a right ureteroscopy with lithotripsy.An access sheath was advanced to the level of the mid pelvic bone allowing the ureteroscope to advance into the ureter over a wire.This allowed stone visualization.A stone was lasered into multiple small fragments.Attempt to retract the scope was unsuccessful.Surgeon able to remove the access sheath, but the scope could not be retracted.The scope could move up but not back, a rotating motion was then done, and this rotation allowed the scope to be removed.However the last 2 cm of the ureteroscope broke off and remained in the pt.

• Brand Name: OLYMPUS
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 7471911
• MDR Text Key: 106954185
• Report Number: MW5076824
• 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: 04/25/2018

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: URF TYPE P5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• 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 Age: 62 YR
• Patient Weight: 131