MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) ELECTRODE, 22FR CUTTING LOOP

Model Number 4622.1333

Device Problem Break (1069)

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

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed as the actual device was returned to rwmic facility on 06/19/2017.Distal wire tips were charred however the distal coating was not melted indicating high power applied to device and once tip cools down it becomes fragile and can easily break off.Lot manufactured date: 11/2016, lot expiration date: 11/2021, purchase date: (b)(6)2017 (1 box of 3).Two similar issues have occurred in the last three years (mdr's 1418479-2015-00002 & 1418479-2015-00030).Rwmic considers this matter closed.However in the event rwmic receives additional information, a follow-up report will be provided.

Event Description

Facility report to richard wolf medical instruments corporation (rwmic) that during a procedure the cutting loop broke off and fell into bladder.Foreign object was able to be retrieved.No injury to patient or staff reported.

• Brand Name: ELECTRODE, 22FR CUTTING LOOP
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; registration #1418479; 353 corporate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 6658086
• MDR Text Key: 78130688
• Report Number: 1418479-2017-00012
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/28/2021
• Device Model Number: 4622.1333
• Device Lot Number: 51006773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 86