MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Procedure performed: laporoscopic total hysterectomy.Event description: surgeon using voyant 5mm fusion on ovarian ligament.Prior registrar had been using the device and causing a lot of seal cycle errors due to accidentally activating the jaws, unfamiliarity with the locking handle.However, the seal cycle was still able to be completed.Surgeon took the device and activated himself, the surgeon sometimes cuts short the seal cycle and causes the seal cycle error.During sealing, the seal cycle would not complete and the generator produced a seal cycle issue - the device was activated twice more and seal cycle would not complete, resulting in seal cycle error.We repositioned the device, away from metal and the cycle would still not complete successfully it was at this point the surgeon swapped the device for a new eb210 and sealed the existing area without issue.Additional information received by applied medical rep via email on (b)(6) 2023: 1the surgeon was trying to seal ovarian tissue, unsure of specific tissue.The device had been in use prior to me attending the case.(no record of number of activations).The issues occurred after the registrar had used the device for roughly 10 activations, however, there were multiple failed activations as the registrar was not comfortable with the device, failing to lock handle, multiple failed activations, repeated pressing off the activation button etc.No activation or end tone was heard ¿ the generator gave the ¿seal cycle failed¿ error and an audible error tone.No thermal effects were visible at the seal site.Type of intervention: device replacement.Patient status: no injury - patient safe.
Additional 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 unintended rf activation could not be replicated as the event unit met specifications.Applied medical was reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: laparoscopic total hysterectomy event description: surgeon using voyant 5mm fusion on ovarian ligament.Prior registrar had been using the device and causing a lot of seal cycle errors due to accidentally activating the jaws, unfamiliarity with the locking handle.However, the seal cycle was still able to be completed.Surgeon took the device and activated himself, the surgeon sometimes cuts short the seal cycle and causes the seal cycle error.During sealing, the seal cycle would not complete and the generator produced a seal cycle issue - the device was activated twice more and seal cycle would not complete, resulting in seal cycle error.We repositioned the device, away from metal and the cycle would still not complete successfully it was at this point the surgeon swapped the device for a new eb210 and sealed the existing area without issue.Additional information received by applied medical rep via email on 26jul23: the surgeon was trying to seal ovarian tissue, unsure of specific tissue.The device had been in use prior to me attending the case.(no record of number of activations).The issues occurred after the registrar had used the device for roughly 10 activations, however, there were multiple failed activations as the registrar was not comfortable with the device, failing to lock handle, multiple failed activations, repeated pressing off the activation button etc.No activation or end tone was heard ¿ the generator gave the ¿seal cycle failed¿ error and an audible error tone.No thermal effects were visible at the seal site.Type of intervention: device replacement patient status: no injury - patient safe.

• Brand Name: EB210, VOYANT 5MM FUSION 37CM, 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: 17494529
• Report Number: 2027111-2023-00552
• Device Sequence Number: 20656460
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)251016(30)01(10)1470746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201212
• 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): 05/15/2024

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: 10/16/2025
• Device Model Number: EB210
• Device Catalogue Number: 101476432
• Device Lot Number: 1470746
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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: GENERATOR
• Patient Sex: Unknown