MAUDE Adverse Event Report: HEALTHTRONICS, INC. LITHODIAMOND LITHOTRIPTOR; LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL

Model Number LITHOTRIPTOR

Device Problems Failure to Power Up (1476); Connection Problem (2900)

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

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated by a field service engineer using simulated use testing.An open circuit was found.The device was repaired and returned to the customer.

Event Description

During procedure set-up, with a patient on the table under anesthesia, the power cord was kicked and lost its connection.Once reconnected, the system would not boot up.Unable to get system up and running so the case was cancelled.

• Brand Name: LITHODIAMOND LITHOTRIPTOR
• Type of Device: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL
• Manufacturer (Section D): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer (Section G): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer Contact: deborah wilcoxen ; 9825 spectrum drive; building 3; austin, TX 78717 ; 5124398334
• MDR Report Key: 6411885
• MDR Text Key: 70375395
• Report Number: 3008262715-2017-00009
• Device Sequence Number: 1
• Product Code: LNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: LITHOTRIPTOR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR