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

Model Number EB240

Device Problem Energy Output Problem (1431)

Patient Problem Blood Loss (2597)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

The event unit has returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: exploratory laparotomy.Event description: the account manager was not present for the case which was an emergent add on case friday evening.The surgery had been cancelled from earlier that day when the patient exhibited signs of a stroke.The patient was a (b)(6)- year old male.The device was plugged in and handed off to the surgeon who started mobilizing with voyant.The first 5 or 6 seals were fine, but the seals after that were not sealing completely.The surgeon stated that device was going through full seal cycles and received the proper end tones.When un-grasping on the mesentery, imp and marginal arteries there was bleeding and the seals did not look complete.At this point he was double and triple sealing as he could not obtain hemostasis.The patient had lost approximately 400cc of blood when the surgeon grabbed ligasure to reseal and was able to obtain hemostasis and complete the case.There was no tension applied to the vessel when being sealed.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.There were no generator alarms that interrupted the seal cycle when the insufficient hemostasis was observed.According to the surgeon the patient did not have any comorbidities, or was taking any medications that would have caused to the bleeding.The device was not activated on diseased, or inflamed tissue.On sunday the patient was readmitted for a distal sigmoid bleed.The bleeding was controlled, and the patient is currently fine.The device is available to be returned.Additional information received via phone on 19nov2020 at 9:58am from applied medical account mgr: account mgr spoke to surgeon today.The patient was readmitted on sunday.The bleeding was controlled and a left hemi-colectomy was performed.The patient received a blood transfusion of 5 units of a blood.The patient is doing fine.Type of intervention: switched to ligasure to complete the case.Patient status: patient was re-admitted due to distal sigmoid bleed.The patient is doing fine.

Event Description

Procedure performed: exploratory laparptomy.Event description: the account manager was not present for the case which was an emergent add on case friday evening.The surgery had been cancelled from earlier that day when the patient exhibited signs of a stroke.The patient was a 91 year old male.The device was plugged in and handed off to the surgeon who started mobilizing with voyant.The first 5 or 6 seals were fine, but the seals after that were not sealing completely.The surgeon stated that device was going through full seal cycles and received the proper end tones.When un-grasping on the mesentery, imp and marginal arteries there was bleeding and the seals did not look complete.At this point he was double and triple sealing as he could not obtain hemostasis.The patient had lost approximately 400cc of blood when the surgeon grabbed ligasure to reseal and was able to obtain hemostasis and complete the case.There was no tension applied to the vessel when being sealed.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.There were no generator alarms that interrupted the seal cycle when the insufficient hemostasis was observed.According to the surgeon the patient did not have any comorbidities or was taking any medications that would have caused to the bleeding.The device was not activated on diseased or inflamed tissue.On sunday the patient was readmitted for a distal sigmoid bleed.The bleeding was controlled and the patient is currently fine.The device is available to be returned.Additional information received via phone on 19nov2020 at 9:58am from applied medical account mgr: account mgr spoke to surgeon today.The patient was readmitted on sunday.The bleeding was controlled and a left hemi-colectomy was performed.The patient received a blood transfusion of 5 units of a blood.The patient is doing fine.Type of intervention: switched to ligasure to complete the case.Patient status: patient was re-admitted due to distal sigmoid bleed.The patient is doing fine.

Manufacturer Narrative

The event unit returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant's experience of insufficient hemostasis could not be replicated, as the event unit met current specifications.Applied medical is unable to determine the exact root 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: 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
• MDR Report Key: 10942505
• MDR Text Key: 219490642
• Report Number: 2027111-2020-00636
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)221107(30)01(10)1395185
• Combination Product (y/n): N
• PMA/PMN Number: K201212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1395185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR; GENERATOR
• Patient Outcome(s): Other
• Patient Age: 91 YR