MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GYN UROL BASIC LAPAROSCOPY

Catalog Number	DYNJ63326G
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 "bovie burned patient's skin while actively using bovie, patient's skin at incision/bovie site needed to be excised because of issue".Per the facility "lots of smoke was present".Per the facility the bovie also "stayed hot and burned through the drape when not activated".No additional information is available at this time.The sample was returned, and the reported issue was confirmed.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2024 "bovie burned patient's skin while actively using bovie, patient's skin at incision/bovie site needed to be excised because of issue".

• Common Device Name: GYN UROL BASIC LAPAROSCOPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21169786
• Report Number: 1423395-2025-00006
• Device Sequence Number: 13135041
• Product Code: LRO
• UDI-Device Identifier: 40198459119850
• UDI-Public: 40198459119850
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ63326G
• Device Lot Number: 24GMB256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown