MAUDE Adverse Event Report: BOSTON SCIENTIFIC LITHOCLAS; LITHROTRIPTOR PROBE

Model Number M0068407160

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 11/07/2017

Event Type  malfunction  

Event Description

Probe is supposed to be replaced after 5 uses.Was only used 2-3x in past 2 years but it broke in half while in nephroscope sheath/ in patient.Removed from patient and continued procedure with lithoclast component.

• Brand Name: LITHOCLAS
• Type of Device: LITHROTRIPTOR PROBE
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7319908
• MDR Text Key: 101771471
• Report Number: 7319908
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/05/2017,03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M0068407160
• Device Catalogue Number: M0068407160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR