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

Model Number	EB230
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: bilateral salpingectomy after c-section.Description: the acct mgr was present for the case.On activation 11, the surgeon was making the last seal on the first fallopian tube.The surgeon double sealed and the tissue stuck to the jaws and there was a small amount of bleeding.The surgeon tried sealing and cutting but the tissue would not come loose.The tissue was clamped from the uterus side and scissors were used to cut and pull the tissue off the jaws.After the 13th activation, the jaws were cleaned with a wet lap, but the blade channel was not run.There was no improvement when the jaws were cleaned.The surgeon started on the 2nd fallopian tube and there was tissue sticking to the jaws from the first activation.The surgeon was able to peel the tissue from the device.The jaws were not submerged in fluid at any point during activation prior to the tissue sticking being observed.The device was not activated on diseased or inflamed tissue.A new handpiece was opened to complete the case.There was no patient injury.The cord was cut, but both the device key and handpiece are available to be returned.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.No visible blood or eschar was observed on the sealing surface of the unit.During functional testing, engineering tested the performance of the device and observed sticking before and after cleaning the jaws.Based on the condition of the returned unit, it is likely that the tissue sticking was caused by eschar accumulation from normal use of the device.
Event or Problem Description
Procedure performed: bilateral salpingectomy after c-section.Description: the acct mgr was present for the case.On activation 11, the surgeon was making the last seal on the first fallopian tube.The surgeon double sealed and the tissue stuck to the jaws and there was a small amount of bleeding.The surgeon tried sealing and cutting but the tissue would not come loose.The tissue was clamped from the uterus side and scissors were used to cut and pull the tissue off the jaws.After the 13th activation, the jaws were cleaned with a wet lap, but the blade channel was not run.There was no improvement when the jaws were cleaned.The surgeon started on the 2nd fallopian tube and there was tissue sticking to the jaws from the first activation.The surgeon was able to peel the tissue from the device.The jaws were not submerged in fluid at any point during activation prior to the tissue sticking being observed.The device was not activated on diseased or inflamed tissue.A new handpiece was opened to complete the case.There was no patient injury.The cord was cut, but both the device key and handpiece are available to be returned.Type of intervention: a new handpiece was opened to complete the case.Patient status: no patient injury.

• Brand Name: EB230, VOYANT FINE FUSION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11891349
• Report Number: 2027111-2021-00511
• Device Sequence Number: 3710466
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)240129(30)01(10)1407115
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 01/29/2024
• Device Model Number: EB230
• Device Catalogue Number: 101474248
• Device Lot Number: 1407115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EA020 ELECTROSURGICAL GENERATOR