MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB017, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB017
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: left hemicolectomy.Event description: left hemicolectomy.During the operation knife in the voyant maryland open fusion has blocked on the tissue.He couldn't open the jaws.He has to resect some tissue to take the device out.Patient was hp positive so they had to dispose the device.Intervention: he has to resect some tissue to take the device out.Patient status: no information has been reported.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
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.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: h6 (health effect code) is being updated to "4582 - no clinical signs, symptoms, or conditions" based on additional information received.
Event or Problem Description
Procedure performed: left hemicolectomy.Event description: left hemicolectomy.During the operation knife in the voyant maryland open fusion has blocked on the tissue.He couldn't open the jaws.He has to resect some tissue to take the device out.Patient was hp positive so they had to dispose the device.Additional information received from distributor via email 24mar23: patient is fine.There were no post operative complications.After they had to resect the tissue to take the device out, surgeon completed the procedure without any advanced electric device.The handle was getting stuck in the latched position preventing the jaws from opening.Surgeon couldn't move handle.It was blocked.Surgeon had to cut tissue trapped in jaws.There was a little bleeding.This was observed once.The device had been used for about 20-30 activations before the experience was observed.Surgeon doesn't remember what tissue type and thickness/size was being cut when the stuck blade was noticed.The jaws were cleaned during the procedure many times by moist gauze.They couldn't clean jaws after that, because they were blocked.Intervention: he has to resect some tissue to take the device out.Patient status: patient is fine.There were no post operative complications.

• Brand Name: EB017, 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: 16546234
• Report Number: 2027111-2023-00377
• Device Sequence Number: 15083244
• Product Code: GEI
• UDI-Device Identifier: 00607915138547
• UDI-Public: (01)00607915138547(17)230525(30)01(10)1437083
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193292
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 05/25/2023
• Device Model Number: EB017
• Device Catalogue Number: 101472454
• Device Lot Number: 1437083
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown