MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. LITHOCLAST; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number 840717

Device Problem Break (1069)

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

Event Date 03/25/2020

Event Type  malfunction  

Event Description

The patient end of the lithoclast broke in half while in use.

• Brand Name: LITHOCLAST
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; 11886 greenville ave ste 120; dallas TX 75243
• MDR Report Key: 10051497
• MDR Text Key: 190774231
• Report Number: 10051497
• 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: 04/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 840717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1