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

Model Number EB217

Device Problem Energy Output Problem (1431)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: wide local excision event description: it was noticed during the case that there was a significant red marks (potential burn) to the skin next to the incision under the armpit and another significant red marks (potential burn on the areola next to the incision.The surgeon made sure that the voyant jaws / metal section between jaws and plastic shaft were not in contact with this section of skin at any point during the case.The only part of the voyant device that came into contact with the skin was the plastic shaft.They were taking the sentinel nodes at the time the mark was seen additional information received via email from territory manager on (b)(6) 2022: there were two marks noticed, one on the areola next to the incision roughly 4mm wide x 8mm long and one next to the incision in the armpit roughly 4mm wide x 8mm long additional information provided by territory manager via email (b)(6) 2022: i spoke with [surgeon] and the patient is fine, nothing further needed to do done, as the burns were superficially and healed naturally.Intervention: nothing further needed to be done, as the burns were superficially and healed naturally.Patient status: patient is fine.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

Event Description

Procedure performed: wide local excision.Event description: it was noticed during the case that there was a significant red marks (potential burn) to the skin next to the incision under the armpit and another significant red marks (potential burn on the areola next to the incision.The surgeon made sure that the voyant jaws / metal section between jaws and plastic shaft were not in contact with this section of skin at any point during the case.The only part of the voyant device that came into contact with the skin was the plastic shaft.They were taking the sentinel nodes at the time the mark was seen.Additional information received via email from territory manager on 10nov2022: there were two marks noticed, one on the areola next to the incision roughly 4mm wide x 8mm long and one next to the incision in the armpit roughly 4mm wide x 8mm long.Additional information provided by territory manager via email 25nov22: i spoke with [health professional] and the patient is fine, nothing further needed to do done, as the burns were superficially and healed naturally.Intervention: nothing further needed to be done, as the burns were superficially and healed naturally.Patient status: patient is fine.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 6/BX
• Type of Device: 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: 15916714
• MDR Text Key: 308162874
• Report Number: 2027111-2022-00845
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250406(30)01(10)1449493
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.