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

Model Number EB216

Device Problem Failure to Conduct (1114)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 09/15/2021

Event Type  Injury  

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 Description

Procedure performed: removal of gangrenous portions of colon.Event description: i received a text from dr [name] on (b)(6) 2021.The text read: "i'm not using anymore cdhb voyant until entire stock replaced as currently defective.I had a massive life threatening bleed due to another cdhb failure of voyant".Patient with gastroparesis: bmi of 70: gangrenous portions of colon to be removed.Voyant worked fine but near the end of the procedure failed on 2 vessels.2 large bleeds occurred and had to be contained.Dr [name] completed the surgery using [device].Device failed on short gastric 4mm vessel.Was cleaned regularly and showed no eschar buildup at the time of it failing.No alarms reported.Adequate pressure was applied to vessel as surgeon has used many times before.This is the 3rd device that has failed for this surgeon.Patient has recovered.Intervention: dr [name] completed the surgery using [device].Patient status: bleeds were contained and hemostasis achieved.Patient has recovered.

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 Description

Procedure performed: removal of gangrenous portions of colon event description: i received a text from dr [name]on (b)(6) 2021.The text read: "i'm not using anymore cdhb voyant until entire stock replaced as currently defective.I had a massive life threatening bleed due to another cdhb failure of voyant".Patient with gastroparesis bmi of 70.Gangrenous portions of colon to be removed.Voyant worked fine but near the end of the procedure failed on 2 vessels.2 large bleeds occurred and had to be contained.Dr [name] completed the surgery using [device].Device failed on short gastric 4mm vessel.Was cleaned regularly and showed no eschar buildup at the time of it failing.No alarms reported.Adequate pressure was applied to vessel as surgeon has used many times before.This is the 3rd device that has failed for this surgeon.Patient has recovered.Additional information received via email from [name] on 01/oct/2021: volume of blood was not measured but was enough to warrant the situation as life threatening.All previous failures of the device were reported in cer's.No associated injury occurred as hemostasis was achieved using [device].Patient has since recovered fully.Intervention: dr [name] completed the surgery using [device].Patient status: bleeds were contained and hemostasis achieved.Patient has recovered.

Event Description

Procedure performed: event description: i received a text from dr [name] on (b)(6) 2021.The text read: "i'm not using anymore cdhb voyant until entire stock replaced as currently defective.I had a massive life threatening bleed due to another cdhb failure of voyant".Patient with gastroparesis bmi of 70 gangrenous portions of colon to be removed.Voyant worked fine but near the end of the procedure failed on 2 vessels.2 large bleeds occurred and had to be contained.Dr [name] completed the surgery using [device].Device failed on short gastric 4mm vessel.Was cleaned regularly and showed no eschar buildup at the time of it failing.No alarms reported.Adequate pressure was applied to vessel as surgeon has used many times before.This is the 3rd device that has failed for this surgeon.Patient has recovered.Additional information received via email from [name] 01/oct/2021: volume of blood was not measured but was enough to warrant the situation as life threatening.All previous failures of the device were reported in cer's.No associated injury occurred as hemostasis was achieved using [device].Patient has since recovered fully.Intervention: dr [name] completed the surgery using [device].Patient status: bleeds were contained and hemostasis achieved.Patient has recovered.

Manufacturer Narrative

The event unit was 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 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
• 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: 12558641
• MDR Text Key: 275137993
• Report Number: 2027111-2021-00654
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)231028(30)01(10)1398547
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K200598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: EB216
• Device Catalogue Number: 101474491
• Device Lot Number: 1398547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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
• Patient Outcome(s): Life Threatening