MAUDE Adverse Event Report: WOLF WOLF LITHOTRIPTOR PROBE

Catalog Number 2135.0905

Device Problem Device Inoperable (1663)

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

Event Date 04/29/2015

Event Type  malfunction  

Event Description

Probe did not work.

• Brand Name: WOLF LITHOTRIPTOR PROBE
• Type of Device: LITHOTRIPTOR PROBE
• Manufacturer (Section D): WOLF
• MDR Report Key: 4824992
• MDR Text Key: 20718784
• Report Number: MW5042950
• Device Sequence Number: 1
• Product Code: FFK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2135.0905
• Device Lot Number: 271131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 22