MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER; CLAMP, VASCULAR

Model Number CH6420

Device Problems Product Quality Problem (1506); Structural Problem (2506)

Patient Problem Burn, Thermal (2530)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Patient lip was burned during a base of tongue biopsy by the v.Mueller neuro/spine bi-polar forceps that was used for cautery during the procedure.Although we are just beginning to investigate, it appears that there was no issue with the instrument, but that the team did not realize the instrument being used was not insulated - had anticipated that only the forceps tip would be activated.We recommend consideration by the manufacturer to possibly mark the packing more prominently that this instrument is not insulated.

• Brand Name: V. MUELLER
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10710667
• MDR Text Key: 212283024
• Report Number: 10710667
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH6420
• Device Catalogue Number: CH6420
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 59