MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. STORZ ULTRASONIC OSCILLATING BURR TIP; LITHOTRIPTOR, ULTRASONIC

Model Number 27093LL

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2018

Event Type  Injury  

Event Description

During a left percutaneous nephrolithotomy, the tip of the sterile disposable ultrasonic oscillating burr tip broke off in pt's kidney.The surgeon was able to remove the tip from the kidney.A new sterile probe was opened and the procedure was completed successfully.Defective device caused unsafe condition.No harm to the pt.

• Brand Name: STORZ ULTRASONIC OSCILLATING BURR TIP
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC.
• MDR Report Key: 8078442
• MDR Text Key: 127587561
• Report Number: MW5081370
• Device Sequence Number: 0
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27093LL
• Device Lot Number: 53071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 102