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 11/25/2021

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: gastric sleeve.Event description: using the device to seal vessels during a sleeve gastrectomy.According to the surgeon, he had complete product failure which led to patient having a life threatening bleed.On this day the surgeon experienced this with 2 devices on 2 patients, one after the next.I will submit a second cer for the other device.The surgeon is unwilling to share any other detail according to the surgeon, life threatening bleeds as a result of a failed seal / product failure.[device] was used [to resolve the situation].Applied trocars and [competitor] stapling [were also used at the time of the event].Intervention: [device] was used.Patient status: stable.

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: gastric sleeve.Event description: using the device to seal vessels during a sleeve gastrectomy.According to the surgeon, he had complete product failure which led to patient having a life threatening bleed.On this day.The surgeon experienced this with 2 devices on 2 patients, one after the next.I will submit a second cer for the other device.The surgeon is unwilling to share any other detail according to the surgeon, life threatening bleeds as a result of a failed seal / product failure.[device] was used [to resolve the situation].Applied trocars and [competitor] stapling [were also used at the time of the event].Intervention: [device] was used.Patient status: stable.

Event Description

Procedure performed: gastric sleeve.Event description: using the device to seal vessels during a sleeve gastrectomy.According to the surgeon, he had complete product failure which led to patient having a life threatening bleed.On this day the surgeon experienced this with 2 devices on 2 patients, one after the next.I will submit a second cer for the other device.The surgeon is unwilling to share any other detail according to the surgeon, life threatening bleeds as a result of a failed seal / product failure.[device] was used [to resolve the situation].Applied trocars and [competitor] stapling [were also used at the time of the event].Intervention: [device] was used.Patient status: stable.

Manufacturer Narrative

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

• 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: 12940854
• MDR Text Key: 286120356
• Report Number: 2027111-2021-00755
• Device Sequence Number: 1
• Product Code: GEI
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 12/20/2021
• Supplement Dates FDA Received: 12/15/2021; 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: APPLIED MEDICAL TROCAR; MEDTRONIC STAPLING
• Patient Outcome(s): Life Threatening