LITHOCLAST PROBE 840-717 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-08 for LITHOCLAST PROBE 840-717 * manufactured by Boston Scientific.

Event Text Entries

[328382] Sonatrobe probe from lithoclast ultra broke during use in the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033121
• MDR Report Key: 543093
• Date Received: 2004-09-08
• Date of Report: 2004-09-08
• Date of Event: 2004-08-30
• Date Added to Maude: 2004-09-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LITHOCLAST PROBE
• Generic Name: *
• Product Code: FGM
• Date Received: 2004-09-08
• Model Number: 840-717
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 532465
• Manufacturer: BOSTON SCIENTIFIC
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-09-08