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	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection noted blood and eschar build up between the jaws, preventing the jaws from opening.Testing confirmed that the jaws of the event unit would not open.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: open left colectomy.Event description: event occurred during an evaluation (tm present).The device worked well the majority of the surgery, being cleaned properly very often (including the blade rail), however, close to the end of the procedure the jaws started sticking with more intensity, even right after cleaning them.In two occasions the surgeon couldn't open the jaws after sealing the tissues, stating that the blade was not retracting to the home position.In both cases the surgeon had to cut the sealed tissues with a scalpel to release the jaws (no implications).The second time it blocked occurred after a few activations from the first time (around 10 activations after a deep cleaning).Just around 5 activations from the second episode until the end of the surgery.Intervention: ni.Patient status: event with no clinical implications.

• 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: 15332352
• Report Number: 2027111-2022-00720
• Device Sequence Number: 15065588
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250206(30)01(10)1442990
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: 02/06/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1442990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• 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: 08/09/2022
• Initial Report FDA Received Date: 08/31/2022
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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