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

Catalog Number 88-9199

Device Problem Flare or Flash (2942)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 12aug2020 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

Per email: we have an incident that happened twice already.We are doing a lap chole and towards the end the l hook where the cord is connected started to glow or ignite and had a small fire.Is there a limit on what the bovie settings are? is there a certain number of uses for the cord? i am trying to figure out what happened.Is there a recall? can you also send me a quote? is it on contract? on 17aug2020 third attempt to customer for more information with no response.Is this from one instrument or two separate cords? please confirm whether or not there was patient impact.Are you able to provide the lot number? do you have photos showing the reported issue? no further information available.

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 10482113
• MDR Text Key: 205282263
• Report Number: 1423507-2020-00031
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other