MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MINOR

Catalog Number	DYNJ901310D
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, while using the cautery device on (b)(6) 2023 "two holes burned through the shaft of the cautery tip causing three small (0.5 cm) superficial burn marks on the patient's nipple and areola".The customer reported due to the angle the surgeon was holding the cautery pencil, the insulated shaft was in contact with the patient's skin when burning through the shaft occurred.The customer reported after the reported incident occurred a new cautery was obtained, the procedure was able to be completed, and the surgeon applied "bacitracin" to the burn areas prior to dressing the area.The customer reported the patient stated she "is doing well and is having no issues".Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, 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 customer, while using the cautery device on 07/31/2023 "two holes burned through the shaft of the cautery tip causing three small (0.5 cm) superficial burn marks on the patient's nipple and areola".

• Common Device Name: MINOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17618467
• Report Number: 1423395-2023-00040
• Device Sequence Number: 2634552
• Product Code: FDE
• UDI-Device Identifier: 10889942565238
• UDI-Public: 10889942565238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/24/2023

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: DYNJ901310D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/24/2023
• 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