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	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: whipple.Event description: progressive sticking of the jaw to tissue.Surgeon preferred to switch to new device due to increasing stickiness.Device jaw was cleaned with sharp instruments after occurrence of the sticking, but was not used after.No patient tissue factors known beforehand.Opened a new.Additional information received by applied medical rep via email on 30may2023: no there was no bleeding, however, according to the surgeon he did not feel comfortable to continue working with the device, mainly because of the potential risk of insufficient hemostasis and / or tearing up previously sealed tissue with the affected device.Additional information received by applied medical rep via email on 1jun2023: we were able to complete the operation with other instruments without danger to the patient (new eb240).We had to cut the voyant out of the tissue with a diathermy knife.When we removed the voyant, the knife was stuck in a position where it was dislocated outside the jaws and thus had not gone back.No tissue damage or bleeding.The use was in hard aponeurosis/scar tissue in the abdominal wall.This was observed once after approximately 2 hours and circa 30 activations.We had to cut the voyant out of the tissue with a diathermy knife.The handle was getting stuck in the latched position preventing the jaws from opening.Intervention: device replacement.Patient status: ok.
Event or Problem Description
Procedure performed: whipple.Event description: progressive sticking of the jaw to tissue.Surgeon preferred to switch to new device due to increasing stickiness.Device jaw was cleaned with sharp instruments after occurrence of the sticking, but was not used after.No patient tissue factors known beforehand.Opened a new.Additional information received by applied medical rep via email on 30may23: no there was no bleeding, however, according to the surgeon he did not feel comfortable to continue working with the device, mainly because of the potential risk of insufficient hemostasis and/or tearing up previously sealed tissue with the affected device.Additional information received by applied medical rep via email on 1jun23: we were able to complete the operation with other instruments without danger to the patient (new eb240) we had to cut the voyant out of the tissue with a diathermy knife.When we removed the voyant, the knife was stuck in a position where it was dislocated outside the jaws and thus had not gone back.No tissue damage or bleeding.The use was in hard aponeurosis/scar tissue in the abdominal wall.This was observed once after approximately 2 hours and circa 30 activations.We had to cut the voyant out of the tissue with a diathermy knife.The handle was getting stuck in the latched position preventing the jaws from opening intervention: device replacement.We had to cut the voyant out of the tissue with a diathermy knife.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of the jaws staying closed.Engineering observed that blood and eschar were present in the blade channel.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by eschar buildup in the blade channel, resulting in the jaws being stuck in the closed position and preventing the jaws from opening.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17647374
• Report Number: 2027111-2023-00582
• Device Sequence Number: 6062841
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)251220(30)01(10)1471237
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/23/2023

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
• Device Expiration Date: 12/20/2025
• Device Model Number: EB217
• Device Catalogue Number: 101476436
• Device Lot Number: 1471237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown