MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: below the knee amputation.Event description: rep was not present for the case.About 3/4 of the way through the case the jaws and handles got stuck in the closed position with the blade exposed.It was noted that the surgeon took a bigger bite of tissue than was recommended.To remove the device, the surgeon cut around it using suturing and tying to control any bleeding.There was no additional tissue damage than what was expected with a bka.The surgeon did try to open the handles of the device but was not able to so they decided to cut the device off of the tissue.The blade lever was not able to return to the forward position.There was no patient injury.Product is available for return.Additional information was received via email on 27sep2022 from account manager once the voyant was removed the surgeon completed the case with a [monopolar device] then cut/tie method.Type of intervention: case was completed with a [monopolar device] and then cut/tie method.Patient status: no patient injury.
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.Engineering observed that the blade was in the forward position and blood and eschar were present in the blade channel.Based on the condition of the returned unit and the description of the event, the reported event was caused by eschar in the blade channel, resulting in the blade being stuck in the forward position, which prevented the jaws from opening.The instructions for use states, "buildup of eschar can negatively affect the device¿s sealing and cutting performance." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Corrections made to report: b1 updated to "adverse event", b2 updated to "required intervention to prevent impairment/damage (devices)".
Event or Problem Description
Procedure performed: below the knee amputation.Event description: rep was not present for the case.About 3/4 of the way through the case the jaws and handles got stuck in the closed position with the blade exposed.It was noted that the surgeon took a bigger bite of tissue than was recommended.To remove the device, the surgeon cut around it using suturing and tying to control any bleeding.There was no additional tissue damage than what was expected with a bka.The surgeon did try to open the handles of the device but was not able to so they decided to cut the device off of the tissue.The blade lever was not able to return to the forward position.There was no patient injury.Product is available for return.Additional information was received via email on 27sep2022 from account manager once the voyant was removed the surgeon completed the case with a [monopolar device] then cut and tie method.Type of intervention: case was completed with a [monopolar device] and then cut/tie method.Patient status: no patient injury.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 15506681
• Report Number: 2027111-2022-00750
• Device Sequence Number: 14882130
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)240825(30)01(10)1459045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2024
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1459045
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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
• Patient Sex: Unknown