MAUDE Adverse Event Report: CAREFUSION, INC UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 88-9199

Device Problems Flare or Flash (2942); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4) on 09jun2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

The following information was received via email: patient was undergoing a laparoscopic cholecystectomy under general anesthesia.One of the cautery cords that is packaged in-house with the lap chole set (#(b)(4)) was in use and working normally when the surgeon noted that it suddenly ceased working.Upon inspection of the cord by the surgeon and the scrub tech, they realized the cord had burned completely through, fracturing the cord into two (2) pieces.No injury to patient or staff.Cautery unit set on "normal cautery level".No further information available.Fda # (b)(4).

Event Description

It was reported that: cautery unit cord burnt/short.Event description per attached email states: pt was undergoing a laparoscopic cholecystectomy under general anesthesia.One of the cautery cords that is packaged in-house with the lap chole set (#18256810-016) was in use and working normally where the surgeon noted that it suddenly ceased working.Upon inspection of the cord by the surgeon an the scrub tech, they realized the cord had burned completely through, fracturing the cord into two (2) pieces.No injury to patient or staff.Cautery unit set on "normal cautery level.".

Manufacturer Narrative

The complaint product and pictures were not returned, so an evaluation was performed based on the limited information available.The instrument at the time of manufacturing would have conformed to all specifications for the production.The root cause for the reported issue is most likely due to wear during maintenance/processing, excessive use and sterilization, and appears to have reached end of life.The lot number provided of 036650 was not found in the supplier¿s system, however they did find lot number 036650 which was produced in 2015, over five years ago.There have been no issues identified with the material or manufacturing process.

• Brand Name: UNIPOLAR BOVIE CORD W/UNIVERSAL PLUG
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10195264
• MDR Text Key: 196433769
• Report Number: 1423507-2020-00019
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K971540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 88-9199
• Device Lot Number: 038650
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 60