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

Model Number EB210

Device Problem Energy Output Problem (1431)

Patient Problem Blood Loss (2597)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Procedure performed: rightsided lap hemi.Event description: patient underwent lap hemicolectomy, rightsided.In post-surgical follow up of the patient in the evening of (b)(6), patient became hypotensive and tachycardic, haemoglobin level dropped with 1.5 points.Blood was administered.Post-surgical bleeding was concluded to be the cause.Patient was stabilised and is recovering.Re-surgery was not considered necessary.Account of the right hemicolectomy surgery received from applied medical representative via email on 24-nov-2020: patient has undergone a left hemicolectomy approximately 20 years ago.This surgery was performed by a different surgeon than the right hemicolectomy performed on the (b)(6) of this year.Historic data of this first surgery is not available.It was deemed possible that there would be adhesions, but there were no other significant expectations prior to starting the procedure.The surgery started as planned.There seemed to be minimal adhesions, maybe less than anticipated.No significant observations up to this point.The ileocolic artery was skeletonized and about to be taken down.The surgeon estimated the vessel to be 6 to 8 millimeters in diameter.The surgeon asked for confirmation that a single seal would be sufficient, versus double sealing.Confirmation was given for voyant's 7mm vessel indication, and that it was up to the clinical decision of the surgeon whether the vessel could be taken down and if he could completely grasp the vessel.In case the surgeon was not sure, he should use sideways overlapping seals before transecting the vessel.The ileocolic artery was sealed with one (1) seal.According to the applied medical representative, there was no excessive traction and there was a good perpendicular angle to the vessel.Immediately after transection, bleeding was observed by both the surgeon and the representative.It appeared to be outside and lateral of the sealing surface, not from the edges of the seal, but from the mesenteric tissue in vicinity of the seal.There was no pulsation observed in this blood lateral of the seal.4 to 5 seals were used to stop the visible bleeding.The surgeon remarked that apparently the sealing performance was inadequate.The surgery continued and the colon was exteriorized.The surgeon wanted to remove some mesentery from the colon and used voyant to do so.After one of the completed seals, the surgeon mentioned that this was what he meant, that the tissue was bleeding.The representative could not see the seal site at this time.The surgeon was asked for the origin and location of the blood.The surgeon indicated that it was the seal surface.This bleeding was stopped with a few additional seals with voyant.The surgery was completed without laparoscopic intra-abdominal inspection after the colon was placed back in the abdomen.In the opinion of the representative, the overall blood loss was minimal, based on the amount of blood in the suction canister.Type of intervention: blood transfusion.Patient status: patient was stabilised and is recovering.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and applied medical was unable to replicate the complainant's experience.In the absence of the event unit, applied medical is unable to confirm whether a product malfunction occurred.Applied medical has reviewed the details surrounding the event and is unable to determine the 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: rightsided lap hemi.Event description: patient underwent lap hemicolectomy, rightsided.In post-surgical follow up of the patient in the evening of november 20th, patient became hypotensive and tachycardic, haemoglobin level dropped with 1.5 points.Blood was administered.Post-surgical bleeding was concluded to be the cause.Patient was stabilised and is recovering.Re-surgery was not considered necessary.Account of the right hemicolectomy surgery received from applied medical representative via email on 24-nov-2020: patient has undergone a left hemicolectomy approximately 20 years ago.This surgery was performed by a different surgeon than the right hemicolectomy performed on the 20th of november of this year.Historic data of this first surgery is not available.It was deemed possible that there would be adhesions, but there were no other significant expectations prior to starting the procedure.The surgery started as planned.There seemed to be minimal adhesions, maybe less than anticipated.No significant observations up to this point.The ileocolic artery was skeletonized and about to be taken down.The surgeon estimated the vessel to be 6 to 8 millimeters in diameter.The surgeon asked for confirmation that a single seal would be sufficient, versus double sealing.Confirmation was given for voyant's 7mm vessel indication, and that it was up to the clinical decision of the surgeon whether the vessel could be taken down and if he could completely grasp the vessel.In case the surgeon was not sure, he should use sideways overlapping seals before transecting the vessel.The ileocolic artery was sealed with one (1) seal.According to the applied medical representative, there was no excessive traction and there was a good perpendicular angle to the vessel.Immediately after transection, bleeding was observed by both the surgeon and the representative.It appeared to be outside and lateral of the sealing surface, not from the edges of the seal, but from the mesenteric tissue in vicinity of the seal.There was no pulsation observed in this blood lateral of the seal.4 to 5 seals were used to stop the visible bleeding.The surgeon remarked that apparently the sealing performance was inadequate.The surgery continued and the colon was exteriorized.The surgeon wanted to remove some mesentery from the colon and used voyant to do so.After one of the completed seals, the surgeon mentioned that this was what he meant, that the tissue was bleeding.The representative could not see the seal site at this time.The surgeon was asked for the origin and location of the blood.The surgeon indicated that it was the seal surface.This bleeding was stopped with a few additional seals with voyant.The surgery was completed without laparoscopic intra-abdominal inspection after the colon was placed back in the abdomen.In the opinion of the representative, the overall blood loss was minimal, based on the amount of blood in the suction canister.Type of intervention: blood transfusion.Patient status: patient was stabilised and is recovering.

• Brand Name: EB210, VOYANT 5MM FUSION 37CM, 6/BX, EO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10993162
• MDR Text Key: 221223473
• Report Number: 2027111-2020-00641
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)230818(30)01(10)1394263
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: EB210
• Device Catalogue Number: 101475492
• Device Lot Number: 1394263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Other