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	01/20/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Procedure performed: abdominal sarcoma.Event description: [translation] the jaws of the device remained blocked, impossible to open it after having coagulated.We were forced to put in another device to cut the vessel and performed a scissor cut.This problem caused an extension of the intervention and a real risk for the patient.Additional information received by applied medical representative via email on 18mar23: abdominal sarcoma.Patient ok.Date of the event: (b)(6) 2023.Bipolar forceps, electrocautery were used.The jaws remained blocked after the coagulation step, there had been no difficulties with the blade before.The tissues were sectioned and then the jaws were forced to be opened there was no associated bleeding.The incident only took place once.They took another eb217.This happened at the beginning of the procedure.Intervention: we were forced to use another clamp to cut the vessel and performed a section with scissors.Device replacement.Patient status: this problem resulted in a longer procedure and a real risk for the patient.Patient ok.
Event or Problem Description
Procedure performed: abdominal sarcoma event description: [translation] the jaws of the device remained blocked, impossible to open it after having coagulated.We were forced to put in another device to cut the vessel and performed a scissor cut.This problem caused an extension of the intervention and a real risk for the patient.Additional information received by applied medical representative via email on 18mar23: abdominal sarcoma.Patient ok.Date of the event: 18mar23.Bipolar forceps, electrocautery were used.The jaws remained blocked after the coagulation step, there had been no difficulties with the blade before.The tissues were sectioned and then the jaws were forced to be opened there was no associated bleeding.The incident only took place once.They took another eb217.This happened at the beginning of the procedure.Additional information received by applied medical representative via email on 5jun23: the eb217 sent back is the good one and it was on the (b)(6) 2023 intervention: we were forced to use another clamp to cut the vessel and performed a section with scissors.Device replacement.Patient status: this problem resulted in a longer procedure and a real risk for the patient.Patient ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of the jaws not opening.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.Correction: b3 (date of event) and d10 (therapy date) is being corrected based on the device log pulled from the returned event unit.

• 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: 16594653
• Report Number: 2027111-2023-00394
• Device Sequence Number: 11518616
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)241116(30)01(10)1434625
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 11/16/2024
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1434625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: BIPOLAR FORCEPS; BIPOLAR FORCEPS; ELECTROCAUTERY; ELECTROCAUTERY; GENERATOR; GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown