RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) JAW INSERT, BIPOLAR, Ø 5 MM; GRASPER INSERT
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Model Number 8394.714 |
Device Problems
Unintended Power Up (1162); Therapy Delivered to Incorrect Body Area (1508); Electrical Shorting (2926)
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Patient Problem
Partial thickness (Second Degree) Burn (2694)
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Event Date 09/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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(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).
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Search Alerts/Recalls
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