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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: bilateral tubal ligation.Event description: as the tissues are grabbed and cut and separated after the tip of the probe grasped the tissue, it was not separated from the tissue.In order to save the tissue, the tip of the probe was separated by dissecting with another energy tool.Additional info received on 10-jan-24: she says the tissue quite thin.The locking mechanism remained stuck and did not separated from tissue.We opened [competitor device] to separate tissue.These informations what all we got from the doctor.Additional info received on 09-february-2024: yes, we can confirm correct device returned.Customer experienced no cutting.We can't confirm.However, we heard device was re-sterilized.They had a hard time separating it from the tissue.But they barely managed to separate them.Yes, they cut around the jaws with another device.Type of intervention: the tip of the probe was separated by dissecting with another energy tool.Patient status: the patient is in a good condition as no injuries were sustained.
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of jaws staying closed.Engineering observed the pawl post, an internal component of the handle, was damaged.Based on the condition of the returned unit, it is likely that the damaged pawl post affected the functionality of the latching mechanism.It is likely that the damaged pawl post resulted from reprocessing of the device.The instructions for use (ifu) state that, ¿this device was designed and tested for single patient use only.Do not reuse or resterilize this device.Reuse, reprocessing, or resterilization may alter the structural and/or functional integrity of the device which may result in patient injury, infection, illness or death.¿ 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: bilateral tubal ligation event description: as the tissues are grabbed and cut and separated after the tip of the probe grasped the tissue, it was not separated from the tissue.In order to save the tissue, the tip of the probe was separated by dissecting with another energy tool.Additional info received on (b)(6) 24: she says the tissue quite thin.The locking mechanism remained stuck and did not separated from tissue.We opened [competitor device] to separate tissue.These informations what all we got from the doctor.Additional info received on (b)(6) 2024: yes, we can confirm correct device returned.Customer experienced no cutting.We can't confirm.However, we heard device was re-sterilized.They had a hard time separating it from the tissue.But they barely managed to separate them.Yes, they cut around the jaws with another device.Type of intervention: the tip of the probe was separated by dissecting with another energy tool.Patient status: the patient is in a good condition as no injuries were sustained.

• 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: 18784809
• Report Number: 2027111-2024-00412
• Device Sequence Number: 7814368
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)250314(30)01(10)1446694
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 03/14/2025
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1446694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown