MAUDE Adverse Event Report: STORZ MEDICAL AG LITHOTRIPTOR, SLX

Model Number 3819

Device Problems Failure to Disconnect (2541); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Allegedly, the operator was conducting a lithotriptor stone fragmentation when an airbag inside the water cushion that inflates to displace water during x-ray imaging of stone was inflated and failed to stop inflating; bag burst.The operator had not delivered all the shocks, but had fragmented the stones enough for removal by a cystoscopy procedure.Cystoscopy procedure was completed when all stones were removed; there was no patient injury.

Manufacturer Narrative

The healthtronics service tech went to the site and evaluated the unit.The airbag ruptured due to over inflation; service tech replaced airbag and tested system, and all operations were functioning correctly.They replaced the water controller board as a precaution.No cause was determined.The lithotripsy procedure was conducted at: (b)(6).

• Brand Name: LITHOTRIPTOR, SLX
• Type of Device: LITHOTRIPTOR
• Manufacturer (Section D): STORZ MEDICAL AG; kreuzlingen ; SZ
• Manufacturer (Section G): STORZ MEDICAL AG -; untereseestrasse 47; kreuzlingen CH-8 280; SZ CH-8280
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3958393
• MDR Text Key: 4612069
• Report Number: 9613347-2014-00029
• Device Sequence Number: 1
• Product Code: LNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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