MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRASOUND PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number	M0068407170
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The ultrasound probe busted.It was removed from the field and a new one was obtained.

• Brand Name: ULTRASOUND PROBE
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough , MA 01752
• MDR Report Key: 7734911
• Report Number: 7734911
• Device Sequence Number: 11017529
• Product Code: FFK
• UDI-Device Identifier: 08714729516613
• UDI-Public: (01)08714729516613
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/19/2018
• Report Date (Section F): 07/20/2018

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
• Operator of Device: Health Professional
• Device Model Number: M0068407170
• Device Catalogue Number: M0068407170
• Device Lot Number: 2240371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76
• Date Report Sent to FDA: 07/20/2018