MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) JAW INSERT, BIPOLAR, Ø 5 MM; GRASPER INSERT

Model Number 8394.714

Device Problems Unintended Power Up (1162); Therapy Delivered to Incorrect Body Area (1508); Electrical Shorting (2926)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed as the actual device was returned to the (b)(4) facility on 09/30/2016.In addition, the handle and bipolar cable being used were also submitted for evaluation.Handle was found to have a slight bend.No other issues with this device.The forceps insert had an electrical short.Electricity most likely traveled from the insert, down the metal handle and to the thumbring where it was making contact with patient's moist skin and caused the burn.No similar events have occurred on this device in the last three years.(b)(4) considers this matter closed.However, in the event (b)(4) receives additional information, a follow-up report will be provided to fda.

Event Description

(b)(6) was recently contact by facility to report a patient received a second degree burn.Prior to the initiation of laparoscopic tubal ligation procedure, device system was lying on patients' abdomen when nurse heard the cautery machine being activate and immediately removed cable from power supply.When device was lifted from patients' abdomen a 1 centimeter second burn was found under thumbring of handle.Forceps insert purchased 12/04/2006, approximately 10 years old.No repair or routine maintenance performed at (b)(4) since purchase.Handle purchased 08/04/2005, approximately 11 years old.Handle repaired on 11/10/2005 and 04/14/2010.Kleppinger system made up of the following: handle id #8384.210 (mdr #1418479-2016-00017); forceps insert id #8394.714 (mdr #1418479-2016-00020); bipolar cable id #unknown (non (b)(4) device).

• Brand Name: JAW INSERT, BIPOLAR, Ø 5 MM
• Type of Device: GRASPER INSERT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 6054764
• MDR Text Key: 58815469
• Report Number: 1418479-2016-00020
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8394.714
• Device Catalogue Number: 8394.714
• Device Lot Number: 249O06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• 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
• Treatment: BIPOLAR CABLE; KLEPPINGER HANDLE; POWER SUPPLY
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 86