MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returning to applied medical.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: exploratory laparotomy and colostomy revision.Event description: surgeon used a surgical ruler during the open case and mentioned that having centimeter markings on the shaft of voyant devices could be beneficial.There were ~4 accidental button presses giving "check device" alarms outside the patient as the surgeon was moving around and would easily bump the activation button but surgeon said that overall open fusion device worked well in this case.Additional information was received via email on 12oct2023 from applied medical representative event occurred outside the patient while the device was not needed to be used.Other devices used throughout the case were endo gia stapler, metal retractor, monopolar pencil, surgical ruler.No patient injury.No resolution was needed.The case was completed with the same device.~ 11 activations had already occurred on tissue prior.Yes, the device jaws were cleaned twice with gauze.Type of intervention: no resolution was needed.The case was completed with the same device.Patient status: no patient injury.
Event or Problem Description
Procedure performed: exploratory laparotomy and colostomy revision.Event description: surgeon used a surgical ruler during the open case and mentioned that having centimeter markings on the shaft of voyant devices could be beneficial.There were ~4 accidental button presses giving "check device" alarms outside the patient as the surgeon was moving around and would easily bump the activation button but surgeon said that overall open fusion device worked well in this case.Additional information was received via email on 12oct2023 from applied medical representative event occurred outside the patient while the device was not needed to be used.Other devices used throughout the case were endo gia stapler, metal retractor, monopolar pencil, surgical ruler.No patient injury.No resolution was needed.The case was completed with the same device.11 activations had already occurred on tissue prior.Yes, the device jaws were cleaned twice with gauze.Type of intervention: no resolution was needed.The case was completed with the same device.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 17961997
• Report Number: 2027111-2023-00641
• Device Sequence Number: 17783369
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)241121(30)01(10)1467488
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 11/21/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1467488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2022
• 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: ENDO GIA STAPLER.; METAL RETRACTOR.; MONOPOLAR PENCIL.; SURGICAL RULER.
• Patient Sex: Unknown