MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB216
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: gastric sleeve.Event description: dr [name] was doing a gastric sleeve procedure.The eb216 towards the end of the case would not activate a second time when he was trying to double seal.I advised dr [name] that we do not recommend double sealing.He said he understands and wanted to anyway.He had the jiggle the activation button a little to get the second activation each time.Secondly when he was finished with eb216, he placed it on the mayo stand and the device activated on its own with the jaws open and nobody touching it.Product is available for return.Additional information received via email 02jun2022.From [name], account manager: patient is fine and should have been released from hospital today.Case was completed with the same device.Device was used to almost the end of case before malfunction occurred (approx.30 activations).The only alarms in the case were an occasional early release alarm.No alarms occurred when the device failed to activate.Jaws were cleaned twice with a moist 4x4.Intervention: case was completed with the same device.Patient status: patient is fine.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing was performed on the event unit.However, the complainant's experience of unintended device activation could not be replicated as the event unit functioned as intended.A fuse switch, an internal component of the unit, was observed to be misaligned upon closer inspection.A misaligned fuse switch could possibly cause unintended device activation.However, applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the of the reported event or confirm that a product malfunction occurred.The root cause of the misaligned fuse switch is unable to be determined.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: gastric sleeve.Event description: dr [name] was doing a gastric sleeve procedure.The eb216 towards the end of the case would not activate a second time when he was trying to double seal.I advised dr [name] that we do not recommend double sealing.He said he understands and wanted to anyway.He had the jiggle the activation button a little to get the second activation each time.Secondly when he was finished with eb216, he placed it on the mayo stand and the device activated on its own with the jaws open and nobody touching it.Product is available for return.Additional information received via email on 02jun2022 from [name], account manager: patient is fine and should have been released from hospital today.Case was completed with the same device.Device was used to almost the end of case before malfunction occurred (approx.30 activations).The only alarms in the case were an occasional early release alarm.No alarms occurred when the device failed to activate.Jaws were cleaned twice with a moist 4x4.Intervention: case was completed with the same device.Patient status: patient is fine.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14756693
• Report Number: 2027111-2022-00639
• Device Sequence Number: 12300598
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)250127(30)01(10)1442992
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 01/27/2025
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1442992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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