MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAPAROTOMY

Catalog Number DYNJ34424K

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/08/2021

Event Type  malfunction  

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 Description

It was reported, "a bovie pen malfunctioned and burnt a patient during a procedure.".

• Type of Device: LAPAROTOMY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11728326
• MDR Text Key: 249700589
• Report Number: 1423395-2021-00022
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10193489399684
• UDI-Public: 10193489399684
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ34424K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 73