MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB230, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: left thyroid lobectomy.Event description: the trial was scheduled to perform a left thyroid lobectomy using the voyant fine fusion device.The surgeon used the device during the surgery.After the surgery, the patient left the room and was doing good.Then, the surgeon has been called back as the patient was bleeding.The surgeon re-operated the patient, saying this was the fault of our device fine fusion.During the reoperation, the surgeon has seen the bleeding was coming from the isthmus because of an hemostasis issue.He doesn't know if it was a user issue with the device.After the reoperation, the patient is doing good.I will see the surgeon again soon and will see if he is willing to continue the trials.The device will need to be picked up at the pharmacy service.Additional information received by email from applied medical representative on 22jan2021: well-balanced hypertension.The patient was not given anticoagulation medicine.Type of intervention: the surgeon re-operated the patient.Patient status: no patient injury or illness occur associated with the complaint event.

Event Description

Procedure performed: left thyroid lobectomy.Event description: the trial was scheduled to perform a left thyroid lobectomy using the voyant fine fusion device.The surgeon used the device during the surgery.After the surgery, the patient left the room and was doing good.Then, the surgeon has been called back as the patient was bleeding.The surgeon re-operated the patient, saying this was the fault of our device fine fusion.During the reoperation, the surgeon has seen the bleeding was coming from the isthmus because of an hemostasis issue.He doesn't know if it was a user issue with the device.After the reoperation, the patient is doing good.I will see the surgeon again soon and will see if he is willing to continue the trials.The device will need to be picked up at the pharmacy service.Additional information received by email from applied medical representative on 22jan21 well-balanced hypertension.The patient was not given anticoagulation medicine.Type of intervention: the surgeon re-operated the patient patient status: no patient injury or illness occur associated with the complaint event.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit; however, the complainant's experience of insufficient hemostasis could not be replicated or confirmed, as the event unit met current specifications.Applied medical is unable to determine the exact root cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: EB230, VOYANT FINE FUSION, 6/BX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11240719
• MDR Text Key: 229091231
• Report Number: 2027111-2021-00315
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 0060791527428
• UDI-Public: (01)0060791527428(17)231008(30)01(10)1397539
• Combination Product (y/n): N
• PMA/PMN Number: K153017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: EB230
• Device Catalogue Number: 101474248
• Device Lot Number: 1397539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other