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	Gastrointestinal Hemorrhage (4476)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
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: 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.
Event or Problem 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.
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 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.
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: 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.

• 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: 12558641
• Report Number: 2027111-2021-00654
• Device Sequence Number: 11086548
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)231028(30)01(10)1398547
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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: 10/28/2023
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 09/27/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/08/2021; 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown