STORZ ULTRASONIC OSCILLATING BURR TIP 27093LL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for STORZ ULTRASONIC OSCILLATING BURR TIP 27093LL manufactured by Karl Storz Endoscopy - America, Inc..

Event Text Entries

[127587561] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081370
• MDR Report Key: 8078442
• Date Received: 2018-11-14
• Date of Report: 2018-11-02
• Date of Event: 2018-10-23
• Date Added to Maude: 2018-11-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: STORZ ULTRASONIC OSCILLATING BURR TIP
• Generic Name: LITHOTRIPTOR, ULTRASONIC
• Product Code: FEO
• Date Received: 2018-11-14
• Model Number: 27093LL
• Lot Number: 53071
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOSCOPY - AMERICA, INC.

Device Sequence Number: 1

• Brand Name: STORZ ULTRASONIC OSCILLATING BURR TIP
• Generic Name: LITHOTRIPTOR, ULTRASONIC
• Product Code: FEO
• Date Received: 2018-11-14
• Model Number: 27093LL
• Lot Number: 53071
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOSCOPY - ANIMAS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-11-14