MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB216
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
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: lap sleeve gastrectomy.Event description: the device was being used to mobilize the stomach from the omentum.The device was being used to seal and transect tissue.Following completion of the seal cycle and transection of tissue, when the jaw was released from the tissue a permanent fused seal did not occur.Blood appeared from the seal margins.The blood did not appear immediately it took approximately 2 seconds.There was no tension on the tissue during the seal cycle.The bleeding appeared consistently from the fourth activation onwards.There was no eschar on the jaws during the activation which caused the bleed.The seal cycle was completed and the end tone heard prior to transection of the tissue.Prior to case it was confirmed that patient had no pre-existing medical conditions or was on any medication that would impact the seal quality.Prior to case surgeon had successfully completed over 10 cases using voyant.Later in the case the black rotation knob also fell off.There were no changes in health resulting from the event.The surgery continued using the voyant device, with multiple seal cycles required to control bleed.Once bleed was controlled the surgeon was able to complete the surgery as per normal.Stomach was grasped to retract, no tissue tension additional information received via email from [name] on 4 april 2022: the black rotation knob did not touch the patient.It slid down the shaft and assistant was able to stop it falling off and pop it back on so was not an issue.Additional information was received via email from [name] on 22 april 2022: the surgeon informed me this morning that the patient had a post operative bleed, drop in hemoglobin.No transfusion was required and the patient is now stable.Additional information was received via email from [name] on 26 april 2022: the patient was hypotensive in recovery (low blood pressure) due to internal bleed but recovered and became stable without reoperation.Intervention: "became stable without reoperation." patient status: "the patient was hypotensive in recovery (low blood pressure) due to internal bleed but recovered and became stable without reoperation.".
Event or Problem Description
Procedure performed: lap sleeve gastrectomy.Event description: the device was being used to mobilize the stomach from the omentum.The device was being used to seal and transect tissue.Following completion of the seal cycle and transection of tissue, when the jaw was released from the tissue a permanent fused seal did not occur.Blood appeared from the seal margins.The blood did not appear immediately it took approximately 2 seconds.There was no tension on the tissue during the seal cycle.The bleeding appeared consistently from the fourth activation onwards.There was no eschar on the jaws during the activation which caused the bleed.The seal cycle was completed and the end tone heard prior to transection of the tissue.Prior to case it was confirmed that patient had no pre-existing medical conditions or was on any medication that would impact the seal quality.Prior to case surgeon had successfully completed over 10 cases using voyant.Later in the case the black rotation knob also fell off.There were no changes in health resulting from the event.The surgery continued using the voyant device, with multiple seal cycles required to control bleed.Once bleed was controlled the surgeon was able to complete the surgery as per normal.Stomach was grasped to retract, no tissue tension.Additional information received via email from [name] on 4 april 2022: the black rotation knob did not touch the patient.It slid down the shaft and assistant was able to stop it falling off and pop it back on so was not an issue.Additional information was received via email from [name] on 22 april 2022: the surgeon informed me this morning that the patient had a post operative bleed, drop in hemoglobin.No transfusion was required and the patient is now stable.Additional information was received via email from [name] on 26 april 2022: the patient was hypotensive in recovery (low blood pressure) due to internal bleed but recovered and became stable without reoperation.Additional information was received via email from [name] on 1 july 2022: the two devices were used in two different sleeve gastrectomy¿s.In the first procedure the product was used until completion and then put in a biohazard bag for return.The surgeon had 6 sleeves that day and each procedure is typically less than an hour operating time.Intervention: "became stable without reoperation".Patient status: "the patient was hypotensive in recovery (low blood pressure) due to internal bleed but recovered and became stable without reoperation.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated, as the event unit passed all relevant testing and met current specifications.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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 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: 14342532
• Report Number: 2027111-2022-00599
• Device Sequence Number: 5221187
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)241017(30)01(10)1432093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2024
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1432093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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
• Patient Sex: Unknown