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

Model Number	4622.1333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 6658086
• Report Number: 1418479-2017-00012
• Device Sequence Number: 16465175
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 86