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U.S. Department of Health and Human Services

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

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KARL STORZ ENDOSCOPY - AMERICA, INC. STORZ ULTRASONIC OSCILLATING BURR TIP; LITHOTRIPTOR, ULTRASONIC Back to Search Results
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.
 
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Brand Name
STORZ ULTRASONIC OSCILLATING BURR TIP
Type of Device
LITHOTRIPTOR, ULTRASONIC
Manufacturer (Section D)
KARL STORZ ENDOSCOPY - AMERICA, INC.
MDR Report Key8078442
MDR Text Key127587561
Report NumberMW5081370
Device Sequence Number0
Product Code FEO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number27093LL
Device Lot Number53071
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/14/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight102
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