MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: wide local excision.Event description: it was noticed at the end of the case that there was a significant red mark (potential burn) to the skin next to the incision under the armpit.The jaws /metal section between jaws and plastic shaft were in contact with this section of skin at some points during the case, including times when the energy was activated.This section of skin was subsequently removed to allow for health skin to be used to close the incision.Additional information received from applied medical representative via email on 13-oct-2022: the patient is okay, the damaged skin was removed and the wound sutured closed as normal.The lot number is: 1449493.The surgeon was sealing and dividing the fatty tissue around close to the lymph nodes with most of the jaws inside the incision and a small amount of the jaw resting on the skin next to the incision.Intervention: the damaged skin was removed and the wound sutured closed as normal.Patient status: the patient is okay.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.No alleged malfunction was noted by the complainant with an applied medical device.Based on the description of the event, it is likely that the reported event was caused by use error.The instructions for use (ifu) warns, "to prevent unintended thermal injury, care should be taken around structures in close proximity to the jaws and during surgical procedures occurring in confined spaces." the instructions for use (ifu) also warns, "after device activation, keep the jaws of the device away from adjacent tissue as the jaws may remain hot enough to cause burns.".
Event or Problem Description
Procedure performed: wide local excision.Event description: it was noticed at the end of the case that there was a significant red mark (potential burn) to the skin next to the incision under the armpit.The jaws / metal section between jaws and plastic shaft were in contact with this section of skin at some points during the case, including times when the energy was activated.This section of skin was subsequently removed to allow for health skin to be used to close the incision additional information received from applied medical representative via email on (b)(6) 2022: the patient is okay, the damaged skin was removed and the wound sutured closed as normal.The lot number is: 1449493 the surgeon was sealing and dividing the fatty tissue around close to the lymph nodes with most of the jaws inside the incision and a small amount of the jaw resting on the skin next to the incision.Intervention: the damaged skin was removed and the wound sutured closed as normal patient status: the patient is okay.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15695154
• Report Number: 2027111-2022-00795
• Device Sequence Number: 7272564
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250406(30)01(10)1449493
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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 Expiration Date: 04/06/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1449493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown