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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: hipec.Event description: hipec - resection and removal of mesenteric root nodule - resection and removal of the anterior quadrant of the greater omentum and previous scar - resection and removal of iliocecal valve implant -resection and removal of the left colon segment.After 4 hours from the start of surgery, the jaw of the device begins to lock, the surgeon seals, cuts and removes the device from the tissue, but does not achieve complete opening of the tips, after several attempts to open and close the jaw.Handle of the device, finally the jaw is completely locked and to unlock it the surgeon has to make several attempts to open and close, all this happens without having tissue in the jaw.Due to the difficulty of performing the surgery and for safety reasons, the surgeon requested a new eb217 device.After 1 hour of use, the device became blocked with the tissue between its jaws, the surgeon sealed, cut and could not open the jaw, performed the opening action and the device did not respond to the opening and closing maneuver.To release the omentum tissue from the mandible of the device, he manually cuts it with scissors and sutures the ends.The surgery continued with [non-applied device] 5 mm x 23 cm.Intervention: to release the omentum tissue from the mandible of the device, he manually cuts it with scissors and sutures the ends.The surgery continued with ligasure maryland 5 mm x 23 cm patient status: favorable during the intervention.
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 confirmed the complainant¿s experience of difficulty opening the jaws.Upon closer inspection, insufficient crimping of the cover tube, a metal component within the shaft, was observed.Based on the condition of the returned unit and the description of the event, the reported event was caused by the insufficient crimping of the cover tube, leading to displacement of the jaws from its intended position during trigger actuation to open the jaws.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: hipec.Event description: hipec - resection and removal of mesenteric root nodule - resection and removal of the anterior quadrant of the greater omentum and previous scar - resection and removal of iliocecal valve implant -resection and removal of the left colon segment.After 4 hours from the start of surgery, the jaw of the device begins to lock, the surgeon seals, cuts and removes the device from the tissue, but does not achieve complete opening of the tips, after several attempts to open and close the jaw.Handle of the device, finally the jaw is completely locked and to unlock it the surgeon has to make several attempts to open and close, all this happens without having tissue in the jaw.Due to the difficulty of performing the surgery and for safety reasons, the surgeon requested a new eb217 device.After 1 hour of use, the device became blocked with the tissue between its jaws, the surgeon sealed, cut and could not open the jaw, performed the opening action and the device did not respond to the opening and closing maneuver.To release the omentum tissue from the mandible of the device, he manually cuts it with scissors and sutures the ends.The surgery continued with [competitor device].Intervention: to release the omentum tissue from the mandible of the device, he manually cuts it with scissors and sutures the ends.The surgery continued with [competitor device] patient status: favorable during the intervention.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15699044
• Report Number: 2027111-2022-00797
• Device Sequence Number: 20390132
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250214(30)01(10)1444898
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1444898
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; LIGASURE MARYLAND 5 MM X 23 CM; SCISSORS; SUTURES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown