MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAPAROTOMY

Catalog Number	DYNJ34424K
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "a bovie pen malfunctioned and burnt a patient during a procedure." email received by facility rn, (b)(6), with additional information related to this incident.Reporter states on (b)(6) 2021 during a left axillary node dissection, left breast needle guided partial mastectomy the bovie pen malfunctioned causing "multiple small burns to tissue due to the cautery tip not seating all the way in the cautery pencil." upon further investigation reporter states, the burns occurred while the surgeon "was cauterizing in the armpit." reporter states, wounds were covered with derma-bond.Follow-up visit with surgeon (b)(6) 2021 and reports "everything looks great." sample has been returned for evaluation.According to division quality assessment report, "based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process." due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, "a bovie pen malfunctioned and burnt a patient during a procedure.".

• Common Device Name: LAPAROTOMY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11728326
• Report Number: 1423395-2021-00022
• Device Sequence Number: 3080885
• Product Code: FDE
• UDI-Device Identifier: 10193489399684
• UDI-Public: 10193489399684
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ34424K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: 75 YR
• Patient Weight: 73