MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: vaginal hysterectomy.Event description: [translation] during a vaginal hysterectomy the instrument no longer "wanted" to tighten the jaws.The surgeon tried taking less thick to see if it was a question of too thick a grip.In vain, the jaws were no longer touching so ineffective, change of forceps, no problem.Additional information received from applied medical representative via email 19sep23: sealing completed showed on the screen.No alarms were received.No errors were received.The activation tone or end tone was heard when the fuse activation button was pressed.The jaws were not locked.Surgeon told us, that it showed sealing completed on the screen without any electricity passed along (no smoke no sealing).Intervention: device replacement patient status: no clinical impact to the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing was performed on the returned unit, where the pull tube, an external component of the shaft, was observed to be skipping the tangs.The complainant¿s experience of the jaw remaining open was confirmed as the pull tube was observed to be bent.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the bent pull tube.The pull tube skipping may result in the jaws failing to close and limiting the pressure applied to tissue during sealing.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit and further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: vaginal hysterectomy.Event description: [translation] during a vaginal hysterectomy the instrument no longer "wanted" to tighten the jaws.The surgeon tried taking less thick to see if it was a question of too thick a grip.In vain, the jaws were no longer touching so ineffective, change of forceps, no problem.Additional information received from applied medical representative via email 19sep2023: sealing completed showed on the screen.No alarms were received.No errors were received.The activation tone or end tone was heard when the fuse activation button was pressed.The jaws were not locked.Surgeon told us, that it showed sealing completed on the screen without any electricity passed along (no smoke no sealing).Additional information received from applied medical representative via email 12feb2024: the customer confirms that ¿no smoke, no sealing¿ was due to ¿the jaws no longer touching.¿ intervention: device replacement.Patient status: no clinical impact to the patient.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 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: 17897197
• Report Number: 2027111-2023-00622
• Device Sequence Number: 17894240
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250801(30)01(10)1462635
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200598
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 08/01/2025
• Device Model Number: EB217
• Device Catalogue Number: 101476436
• Device Lot Number: 1462635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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