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

Model Number EB240

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: unknown.Event description: the event date is unknown.We had some issues using your voyant devices.Below is what was noted on the adverse event form: during the intervention the device hangs on the tissues to be cut device impossible to unlock the surgeon manages to release the jaws of the device but it remains blocked change of device (same batch) the device also hangs and when it is removed the surgeon notices a burn on the vulva on the left side ie on the clamp side.So these are 2 voyant devices from the same batch isolation of voyant devices from the same batch rus info and pharmacist call.Type of intervention: change of device.Patient status: when it is removed the surgeon notices a burn on the vulva on the left side ie on the clamp side.

Event Description

Procedure performed: vaginal hysterectomy.Event description: the event date is unknown.We had some issues using your voyant devices.Below is what was noted on the adverse event form: during the intervention the device hangs on the tissues to be cut device impossible to unlock the surgeon manages to release the jaws of the device but it remains blocked change of device (same batch) the device also hangs and when it is removed the surgeon notices a burn on the vulva on the left side ie on the clamp side so these are 2 voyant devices from the same batch isolation of voyant devices from the same batch rus info and pharmacist call additional information received by email from applied medical representative on 17mar22 name of procedure being performed: vaginal hysterectomy patient status : burning of the vulva the surgeon saw the patient 3 weeks later and it was ok for her the blade lever was not still engaged when the surgeon was attempting to unlatch the handle this was observed several times and then the device was completely blocked.He used another one and the device was still blocked but he reached to finish the intervention.During 10-15 minutes the device worked well and then it was blocked.Around 10 activations the surgeon was unable to unlatch the handle he had to pull on the device to get the device out, next he tried to open the jaw outside without success there was a superficiella burnt of the vulva but not with a specific side of the device, it seems that it was a thermal spread of the jaws."info rus" stands for care unit manager by "device hangs on tissue" it was the nurse feeling and it was the moment that the jaws was blocked with tissues inside by the device "remains blocked" the surgeon told me that it was both the handle and blade lever the part of the device that caused the burn was the jaws type of intervention: change of device patient status: burning of the vulva the surgeon saw the patient 3 weeks later and it was ok for her.

Manufacturer Narrative

The event unit was returned applied medical for evaluation.However, the complainant's experience of thermal spread could not be confirmed or replicated as the conditions of the returned unit prevented the device from being able to activate.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• Type of Device: 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: 13831140
• MDR Text Key: 289444249
• Report Number: 2027111-2022-00484
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)230928(30)01(10)1423765
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1423765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Other