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

Model Number FR-284

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

During procedure, item broke into two pieces.

• Brand Name: LITHOCLAST
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; 11886 greenville ave ste 120; dallas TX 75243
• MDR Report Key: 13948873
• MDR Text Key: 288195499
• Report Number: 13948873
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2022

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: FR-284
• Device Catalogue Number: M0068402940
• Device Lot Number: 182171A
• 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: 03/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male