MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) BIPOLAR WORKING ELEMENT

Model Number 8680.224

Device Problems Electrical /Electronic Property Problem (1198); Failure To Service (1563); Inappropriate/Inadequate Shock/Stimulation (1574); Component Missing (2306); Device Issue (2379)

Patient Problems Burn, Thermal (2530); Electric Shock (2554)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation revealed device was missing screw and thumb ring.Device also had an electrical short.In addition, the device is over two years old and had never been submitted to rwmic for any repairs or routine maintenance.Manufacture date: 12/2012.Purchase date: (b)(6) 2013.Additional information requested concerning the event, no response as of 10/07/2015.Rwmic considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

Event Description

During a case the device became hot and doctor felt a shock.After case completed doctor noticed burn on finger.

Manufacturer Narrative

User facility submitted additional information on 10/21/2015.Added patient information and initial reporter information.

• Brand Name: BIPOLAR WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 5135923
• MDR Text Key: 27766899
• Report Number: 1418479-2015-00034
• Device Sequence Number: 1
• Product Code: FDC
• 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: Service Personnel
• Type of Report: Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: 179D12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR