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

Model Number MEDSTONE STS-T

Device Problem Failure to Fire (2610)

Patient Problem No Code Available (3191)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) evaluated system and confirmed issue.Error codes observed.Parts ordered and replaced.Performed operational test and observed cases.System tested in accordance with manufacturers service manual.Service management reviewing findings provided by field service engineer.Once final review is complete, a follow-up mdr will be submitted.Requests made for patient information.Once received, information will be submitted on follow-up mdr.

Event Description

Field service engineer reported that during service, he became aware that the system quit firing in the middle of the case.Patient had to be retreated.

Manufacturer Narrative

Service management review found part installed during annual pm had prematurely failed.Part was returned doa.Doa inspection determined the power cable came disconnected from the computer power supply.

• Brand Name: MEDSTONE STS-T 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: 5210822
• MDR Text Key: 31081534
• Report Number: 3008262715-2015-00016
• Device Sequence Number: 1
• Product Code: LNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MEDSTONE STS-T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/1998
• 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: 61 YR