MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number M0068402910

Device Problem Break (1069)

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

Event Date 04/10/2019

Event Type  malfunction  

Event Description

While in use per manufacturer's instructions, the boston scientific swiss lithoclast trilogy disposable probe broke in half during use.Probe broke (cleanly) while within the nephroscope and was immediately recovered and removed from the field.Company representative (b)(4) present.Fda safety report id (b)(4).

• Brand Name: SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.; marlborough MA 01752
• MDR Report Key: 8515271
• MDR Text Key: 142196393
• Report Number: MW5085865
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: M0068402910
• Device Catalogue Number: M0068402910
• Device Lot Number: 166562A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR