MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENT CORP. ELECTROHYDRAULIC LITHOTRIPTOR; NONE

Model Number 2135.0905 9FR

Device Problem Device Inoperable (1663)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

(b)(6) y/o male in the operating room for laser cystolitholapaxy.During usage, lithotriptor used and device function stopped.Another one used and surgeon noted a metallic foreign body in bladder.Foreign body retrieved.

• Brand Name: ELECTROHYDRAULIC LITHOTRIPTOR
• Type of Device: NONE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENT CORP.; vernan hills IL 60061
• MDR Report Key: 3767222
• MDR Text Key: 4487387
• Report Number: 3767222
• Device Sequence Number: 1
• Product Code: FFK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2135.0905 9FR
• Device Lot Number: 529131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 04/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR