MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP PROBES, HL, RIWOLITH, 9FR

Model Number 2135.0905

Device Problems Device Inoperable (1663); Solder Joint Fracture (2324)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

Facility notified richard wolf medical instruments corp (rwmic) that during a laser cystolitholapaxy procedure, the device stopped functioning.Surgeon switched to another similar device to complete procedure.Before procedure was completed surgeon found a metallic foreign body in the bladder.Foreign body was retrieved by surgeon.No injury to pt or staff reported.

Manufacturer Narrative

A full investigation could not be completed as the actual device was not returned to the richard wolf facility as of 05/20/2014.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions.Trending showed there has been one similar incident in the last four years.(mdr1418479-2010-00020).Rwmic considers this matter closed.However, in the event we received the device or additional information is received, we will provide fda with follow-up information.

• Brand Name: PROBES, HL, RIWOLITH, 9FR
• Type of Device: PROBE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP; 353 corp woods parkway; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3959125
• MDR Text Key: 4613117
• Report Number: 1418479-2014-00029
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2135.0905
• Device Catalogue Number: 2135.0905
• Device Lot Number: 529131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR