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  

Event Description

Procedure performed: lap sleeve gastrectomy.Event description: this is a cer submission in addition to event (b)(6).On the day the surgeon had 2 patients in which 2 devices failed.This is the second case and second device.Complete product failure while using the device to seal a vessel, leading to a life threatening bleed according to the surgeon, complete product failure when being used to seal of an important vessel.2 devices in 1 day on 2 different patients yes, the product failure led to a life threatening bleed according to the surgeon a [competitor] device was opened [to resolve the situation] and the surgeon has now stated that he will no longer be using voyant as a result of repeated cer's.Am trocars and [competitor] stapling [were used at the time of the procedure].Intervention: a [competitor] device was opened.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.

Event Description

Procedure performed: lap sleeve gastrectomy.Event description: this is a cer submission in addition to event id (b)(4).On the day the surgeon had 2 patients in which 2 devices failed.This is the second case and second device.Complete product failure while using the device to seal a vessel, leading to a life threatening bleed.According to the surgeon, complete product failure when being used to seal of an important vessel.2 devices in 1 day on 2 different patients.Yes, the product failure led to a life threatening bleed according to the surgeon.A [competitor] device was opened [to resolve the situation] and the surgeon has now stated that he will no longer be using voyant as a result of repeated cer's.Am trocars and [competitor] stapling [were used at the time of the procedure].Intervention: a [competitor] device was opened.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.

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: lap sleeve gastrectomy event description: this is a cer submission in addition to event id 3721.On the day the surgeon had 2 patients in which 2 devices failed.This is the second case and second device.Complete product failure while using the device to seal a vessel, leading to a life threatening bleed according to the surgeon, complete product failure when being used to seal of an important vessel.2 devices in 1 day on 2 different patients yes, the product failure led to a life threatening bleed according to the surgeon a [competitor] device was opened [to resolve the situation] and the surgeon has now stated that he will no longer be using voyant as a result of repeated cer's.Am trocars and [competitor] stapling [were used at the time of the procedure].Intervention: a [competitor] device was opened.Patient status: stable.

• 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: 12940828
• MDR Text Key: 285546471
• Report Number: 2027111-2021-00756
• 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

• Date FDA Received: 12/06/2021
• 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
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AM TROCARS; MEDTRONIC STAPLING
• Patient Outcome(s): Life Threatening