MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. FORCEPS, BIPOLAR, KLEPPINGER

Model Number 8384.240

Device Problem Bent (1059)

Patient Problem Burn(s) (1757)

Event Type  No Answer Provided  

Event Description

Customer originally notified richard wolf medical instruments corp (rwmic) to report the generator would only perform at the maximum level, not at the minimum level.After device was received, a follow up call regarding replacement of device was done.At that time, additional information was reported, system caused a burn.The devices below combine to make one system, and these were the devices being used during the procedure, they consist of the following: generator (2352.011) report 1418479-2014-00036, forceps (8384.240) report 1418479-2014-00037, jaw insert (8394.714) report 1418479-2014-00038, footswitch (2030.103), report 1418479-2014-00039.

Manufacturer Narrative

An investigation was completed on 06/30/2014 as the actual device was returned to the rwmic facility.Shaft was bent.Device on its own is not capable of producing enough energy to cause a burn.Device history: no record of any repairs or routine maintenance of device.No similar issues reported in last three years although many devices have been returned to be repaired due to being bent.Root cause due to handling by user.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

• Brand Name: FORCEPS, BIPOLAR, KLEPPINGER
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: dawn blark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 3981339
• MDR Text Key: 4748162
• Report Number: 1418479-2014-00037
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8384.240
• Device Catalogue Number: 8384.240
• Device Lot Number: 94Y08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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