ELECTRO LUBE
Received Apr 21, 2022
Report 2183785-2022-00001 · MDR key 14173229
Device
Generic name
Electrosurgical Accessory
Manufacturer
Key Surgical, LlcProduct problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS REQUESTED FROM THE CUSTOMER; HOWEVER, TO DATE, WE HAVE NOT RECEIVED A RESPONSE. THE SPONGE IS AN ACCESSORY TO THE ELECTRO LUBE. THE LOT NUMBER OF THE ELECTRO LUBE SUBJECT OF THE EVENT IS UNKNOWN. THE ELECTRO LUBE INSTRUCTIONS FOR USE STATES, "1. DISPENSE POUCH CONTENTS ONTO STERILE FIELD. 2. REMOVE PAPER BACKING FROM FOAM PAD AND PLACE FOAM PAD ONTO STERILE DRAPE. NOTE: THE FOAM PAD INCLUDES A BARIUM FILAMENT FOR RADIOPACITY. 3. REMOVE CAP AND APPLY ELECTRO LUBE ONTO FOAM PAD OR DIP ELECTRODE TIP INTO BOTTLE. 4. WIPE ELECTRODE TIP ON FOAM PAD TO LEAVE A THIN FILM. 5. REPEAT AS NEEDED." A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT PIECES OF THE ELECTRO LUBE PURPLE SPONGE ARE COMING OFF ONTO THE TIP OF THE ELECTROSURGERY INSTRUMENT DURING PATIENT PROCEDURES. USER FACILITY PERSONNEL UTILIZED A NEW ELECTROSURGERY INSTRUMENT TO COMPLETE THE PROCEDURES RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.