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

Model Number M0068407170

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Event Description

During percutaneous nephrolithomy case, md was using ultrasound lithotripsy to break up kidney stones. The ultrasound probe used to operate the lithotripsy within the nephroscope broke in half midway through the procedure. The broken piece was removed from the sterile field, and a new ultrasound probe was given to md.

• Brand Name: ULTRASOUND PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8455209
• Report Number: 8455209
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M0068407170
• Device Catalogue Number: M0068407170
• Device Lot Number: 23023809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Patient Age: 22265 DA