MAUDE Adverse Event Report: CAREFUSION, INC CUSHING MICRO BIPOLAR FORCEPS .7MM 6IN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number F-2000

Device Problem Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Pr # (b)(4) 07oct2020 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: it was reported that the patient got a second-degree burn using the top of the forcep on the upper lip.Patient got a 2nd degree burn on upper lip from top of forcep when using it inside the mouth.It was the top of the forcep near the part that attaches to the cord that got hot, not where the tips are.No further information available.

Manufacturer Narrative

Follow up (b)(4).The product was returned, and an evaluation was performed.The root cause of this reported issue was not confirmed.The subject device was tested to see if electricity flows through forcep arms to the tips.The results indicated that the subject device performed as expected, and passed acceptance criteria.No issues identified with dhr.The supplier is unable to identify root cause, as the returned device performs as intended, with no device malfunction.Please note that the bipolar forcep type, the subject of this investigation, is non-insulated.It is of the manufacturer¿s opinion that an insulated bipolar forcep should have been used for this type of surgical procedure.However, the type of bipolar forcep selected for a procedure is made at the discretion of the surgeon.This is an isolated incident.The product has been manufactured and tested according to the specifications.H3 other text : see h10.

Event Description

Per email: it was reported that the patient got a second-degree burn using the top of the forcep on the upper lip.Patient got a 2nd degree burn on upper lip from top of forcep when using it inside the mouth.It was the top of the forcep near the part that attaches to the cord that got hot, not where the tips are.No further information available.

• Brand Name: CUSHING MICRO BIPOLAR FORCEPS .7MM 6IN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10717361
• MDR Text Key: 212462177
• Report Number: 1423507-2020-00050
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K974593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: F-2000
• Device Lot Number: T1709266
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention