MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. ELECTRODE, 22/24FR HOOK, 5/BX

Model Number 8423.0905

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

(b)(4) was notified that during a procedure, a piece of the device broke off inside the pt bladder.Foreign object was easily removed with minimal delay in procedure.Facility had backup device available and was able to complete the procedure.No injuries to pt or staff were reported.

Manufacturer Narrative

An investigation will be completed as the actual device was returned to (b)(4) and will be sent to mfr for investigation on (b)(4) 2015.(b)(4) considers this matter closed.However, in the event we receive additional info, we will provide mfr with follow-up info.

• Brand Name: ELECTRODE, 22/24FR HOOK, 5/BX
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; pforzheimer strabe 32; GM
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: 353 corporate woods pkwy.; vernon hills, IL 60061
• MDR Report Key: 4610014
• MDR Text Key: 21564338
• Report Number: 1418479-2015-00003
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2015,02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8423.0905
• Device Catalogue Number: 8423.0905
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2015
• Distributor Facility Aware Date: 02/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1