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

Model Number 8383.21

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation could not be completed as the actual device was not returned to the rwmic facility as of 07/21/2015.In addition, several attempts for additional information as well as photos of device in question were requested.No information or photos submitted as of 07/21/2015.No similar issues have occurred on this device in the last ten years.No serial number of device given, unable to determine actual age of device.Based on purchase history device was purchased prior to 2004.(at least 10 years old).Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions regarding high temperatures and irrigation fluid.Rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to fda.

Event Description

Richard wolf medical instrument corp.(rwmic) was notified by facility that a patient was burned sometime during a procedure.Facility used a few different devices during the procedure, the following is the suspect device: jaw insert ((b)(4)).Report (b)(4).The above device work in conjunction with the following devices: bipolar forceps, bipolar cable, generator, foot switch.

Manufacturer Narrative

Facility replacing device with new one.

Event Description

Upon further investigation, reporting facility is now reporting that during a bilateral tubal ligation, the insert adhered to the tube and did not release and thus a there was a fear insert may have touched or burned the ovary.A thorough exam, done by the surgeon, there was no burn.

• Brand Name: FORCEPS, BIPOLAR
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: dawn clark ; 353 corporate woods pkwy.; vernon hills, IL 60061 ; 8479558016
• MDR Report Key: 4939884
• MDR Text Key: 22461674
• Report Number: 1418479-2015-00019
• 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: Not Applicable
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8383.21
• Device Catalogue Number: 8383.21
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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