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	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be 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 incision.Event description: device was being used to seal and cut breast tissue.Eb217 was being used in the incision to seal breast tissue, the plastic shaft of voyant was lent against the skin next to the incision, when the shaft was moved to the other side of the incision to seal different breast tissue, it was noticed that there was a small burn mark on the skin, caused by the shaft of voyant.It caused a small superferical burn.Small superficial burn, should recover normally.Continued to use to the remainder to the case.Intervention: continued to use to the remainder to the case.Patient status: small superficial burn, should recover normally.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit.However, the complainant¿s experience could not be replicated or confirmed as the device passed all relevant testing and functioned as intended.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.
Event or Problem Description
Procedure performed: wide local incision event description: device was being used to seal and cut breast tissue.Eb217 was being used in the incision to seal breast tissue, the plastic shaft of voyant was lent against the skin next to the incision, when the shaft was moved to the other side of the incision to seal different breast tissue, it was noticed that there was a small burn mark on the skin, caused by the shaft of voyant.It caused a small superferical burn.Small superficial burn, should recover normally.Continued to use to the remainder to the case.Intervention: continued to use to the remainder to the case patient status: small superficial burn, should recover normally.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17431145
• Report Number: 2027111-2023-00542
• Device Sequence Number: 6780173
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)260122(30)01(10)1471238
• 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): 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2026
• Device Model Number: EB217
• Device Catalogue Number: 101476436
• Device Lot Number: 1471238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/08/2023
• Supplement Date Received by Manufacturer: 07/08/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: LANGENBECK RETRACTORS.; SIMILAR RETRACTOR.
• Patient Sex: Unknown