MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB030, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	101223301
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation but lot number is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: left thyroidectomy.Incident description: the rep was present for the case.The surgeon went to seal a larger vessel when the jaws got stuck.He tried various methods to remove the jaws, but could not remove them.He had to rip the vessel to remove the jaws.He cut and sutured to repair the vessel.A new handpiece was opened to complete the case.When discussing the case with the rep he mentioned that he had sealed through muscle and had more sticking after doing so.Patient is stable and was fine after vessel was repaired.Additional information received via email on (b)(6) 2019, applied medical account mgr i've answered all other questions with the cer i started yesterday with you.To try to remove the jaws from the vessel, they poured saline on the vessel attached to jaws.Used clamps to remove jaws from tissue.The jaws did not get locked on the latched position.The handle was not getting stuck in the latched position preventing the jaws from opening.The blade lever was not returning to the forward position when released.There was tissue damage and bleeding.There was one incident of this.The surgeon had to remove the vessel that was stuck to the jaws with saline and clamps.Sticking lead to bleeding.Muscle and thyroid tissue were being sealed when the tissue was sticking.After surgeon sealed through muscle the fine fusion started sticking almost every seal.Yes he attempted to seal multiple times on the same seal site; he tried to use his monopolar and bipolar energy to help with sealing and bleeding when fine fusion began sticking.The device was used 20 activations before the surgeon noticed the tissue sticking.Wasn't sticking until surgeon sealed through muscle at 20 activations.The jaws of the device were cleaned after every 2-3 seals during the procedure.The surgeon did notice an improvement when the jaws were cleaned.Saline as applied when jaws were stuck to vessel and would not come off.It is unknown where along the seal site with respect to the jaw was the tissue sticking observed.Saline and clamps were used to remove the stuck tissue from the jaws.The jaws were not submerged in fluid at any point during activation prior to tissue sticking being observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.Intervention: cut & suture to repair vessel.Opened another handpiece to complete case.Patient status: patient is stable and was fine after vessel was repaired.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, eschar buildup was observed on the sealing surface of the device.Testing was performed on the event unit, which confirmed that the device was sticking to tissue.However, there was less sticking after the device sealing surfaces of the device were cleaned.Based on the condition of the returned unit and the description of the event, the exact root cause of the reported event could not be confirmed.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: left thyroidectomy.Incident description: the rep was present for the case.The surgeon went to seal a larger vessel when the jaws got stuck.He tried various methods to remove the jaws, but could not remove them.He had to rip the vessel to remove the jaws.He cut and sutured to repair the vessel.A new handpiece was opened to complete the case.When discussing the case with the rep he mentioned that he had sealed through muscle and had more sticking after doing so.Patient is stable and was fine after vessel was repaired.Additional information received via email on 20sep2019, applied medical account mgr i've answered all other questions with the cer i started yesterday with you.To try to remove the jaws from the vessel, they poured saline on the vessel attached to jaws.Used clamps to remove jaws from tissue.The jaws did not get locked on the latched position.The handle was not getting stuck in the latched position preventing the jaws from opening.The blade lever was not returning to the forward position when released.There was tissue damage and bleeding.There was one incident of this.The surgeon had to remove the vessel that was stuck to the jaws with saline and clamps.Sticking lead to bleeding.Muscle and thyroid tissue were being sealed when the tissue was sticking.After surgeon sealed through muscle the fine fusion started sticking almost every seal.Yes he attempted to seal multiple times on the same seal site; he tried to use his monopolar and bipolar energy to help with sealing and bleeding when fine fusion began sticking.The device was used 20 activations before the surgeon noticed the tissue sticking.Wasn't sticking until surgeon sealed through muscle at 20 activations.The jaws of the device were cleaned after every 2-3 seals during the procedure.The surgeon did notice an improvement when the jaws were cleaned.Saline as applied when jaws were stuck to vessel and would not come off.It is unknown where along the seal site with respect to the jaw was the tissue sticking observed.Saline and clamps were used to remove the stuck tissue from the jaws.The jaws were not submerged in fluid at any point during activation prior to tissue sticking being observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.Additional information received via email on 02oct2019 from applied medical account mgr "they said that they can send back the handpiece they just need all the paperwork in order to get it sent that to you." intervention: cut & suture to repair vessel.Opened another handpiece to complete case.Patient status: patient is stable and was fine after vessel was repaired.

• Brand Name: EB030, VOYANT FINE FUSION, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9136882
• Report Number: 2027111-2019-00605
• Device Sequence Number: 14214660
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)201127(30)01(10)1357607
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 05/30/2019
• Device Model Number: 101223301
• Device Catalogue Number: EB030
• Device Lot Number: 1357607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention