MAUDE Adverse Event Report: CAREFUSION, INC V MUELLER VENA CAVA CLAMP CVD JAW 38X6MM; VASCULAR CLAMP

Model Number	CH6420
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 28oct2020 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 available.
Event or Problem Description
Material no.: ch6420 , batch no.: unknown.It was reported the patient got burned during procedure.Per medwatch: 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.
Additional Manufacturer Narrative
Complaint number: (b)(4) was opened and an initial mdr was submitted based on a medwatch#: 33003000000-2020-8009 we received for the product listed in suspect medical device in section d#: 4 as product number: ch6420.However, when clarified with the customer why it says ¿v mueller with the neuro/spine bi-polar forceps¿ in the description, she said that it was supposed to be submitted for nl1552 - titan bipol bay fine tip.5mm str forcep.We have opened complaint: (b)(4) to capture the correct instrument of nl1552 and an mdr for this product will be submitted.H3 other text.
Event or Problem Description
Per medwatch: patient lip was burned during a base of tongue biopsyby 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.No further information available.

• Brand Name: V MUELLER VENA CAVA CLAMP CVD JAW 38X6MM
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10841013
• Report Number: 1423507-2020-00055
• Device Sequence Number: 4177585
• Product Code: DXC
• UDI-Device Identifier: 10885403031519
• UDI-Public: (01)10885403031519
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CH6420
• Device Catalogue Number: CH6420
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/14/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 59