MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EB210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: bariatric surgery.Event description: [user facility]."bleeding occurred during laparoscopic bariatric surgery because the vessel was not completely sealed while cutting the large vessel.They say it does not seal the large veins.In addition, since the patient's life-threatening situation increased, open surgery was immediately performed" as per the adverse event report that was submitted to the health authority: "in the letter; it is stated that in a laparoscopic obesity case, bleeding occurred because the vessel could not be completely sealed during the large vessel cutting procedure, and therefore, the patient's life risk increased and had to return to emergency open surgery".Additional information received from distributor via email on november 30, 2022: drs and members involved in the surgery: [surgeon] - gynecological oncologist [name] - obstetrics operating room manager [name] - general operating room manager the product was thrown in the trash.The distributor replaced the item.No patient injury, the surgery was changed from laparoscopic to open surgery.The patient status is good.There was a general leak when the sales team was there but the doctor says he was bleeding in the large vessels.One of the arteries above the stomach was being sealed.There was no tension on the vessel.Doctor says there is no eschar.The doctor says "we cleaned but nothing changed".When homostasis started they changed the prob and started using another brand no generator alarms.No vascular pothology was exhibited.The device was not activated on inflammed tissue.Additional information received from distributor via email on december 5, 2022: conversion to open surgery was not part of the planned procedure.Eb215 and eb210 which had cers did not occur in the same surgery but they say the same incident occured on both products.Leakage occured during surgery.Intervention: open surgery was performed.Patient status: good.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: bariatric surgery.Event description: [user facility] "bleeding occurred during laparoscopic bariatric surgery because the vessel was not completely sealed while cutting the large vessel.They say it does not seal the large veins.In addition, since the patient's life-threatening situation increased, open surgery was immediately performed ".As per the adverse event report that was submitted to the health authority: "in the letter; it is stated that in a laparoscopic obesity case, bleeding occurred because the vessel could not be completely sealed during the large vessel cutting procedure, and therefore, the patient's life risk increased and had to return to emergency open surgery".Additional information received from distributor via email on november 30, 2022: drs and members involved in the surgery: [surgeon] - gynecological oncologist [name] - obstetrics operating room manager [name] - general operating room manager the product was thrown in the trash the distributor replaced the item no patient injury, the surgery was changed from laparoscopic to open surgery the patient status is good.There was a general leak when the sales team was there but the doctor says he was bleeding in the large vessels.One of the arteries above the stomach was being sealed there was no tension on the vessel doctor says there is no eschar.The doctor says "we cleaned but nothing changed" when homostasis started they changed the prob and started using another brand no generator alarms.No vascular pothology was exhibited.The device was not activated on inflammed tissue.Additional information received from distributor via email on december 5, 2022: conversion to open surgery was not part of the planned procedure.Eb215 and eb210 which had cers did not occure in the same surgery but they say the same incident occured on both products.Leakage occured during surgery.Intervention: open surgery was performed.Patient status: good.

• Brand Name: EB210, VOYANT 5MM FUSION 37CM, 6/BX
• 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: 15925335
• MDR Text Key: 304908814
• Report Number: 2027111-2022-00848
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)250302(30)01(10)1444902
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K201212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1444902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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: VOYANT GENERATOR
• Patient Outcome(s): Required Intervention; Other; Life Threatening