MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB015, VOYANT MARYLAND FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB015
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed: colon procedure.Two complaints have been created from this report.Complaint # (b)(4) (1 out of 2).Complaint #(b)(4) (2 out of 2).Limited information available at this time.The rep was not present during the case.The jaws of the device was placed on the tissue and the fuse activation button was activated.The generator went through the full seal tones, including the end tone.The surgeon then cut the tissue with the blade lever.When the jaws were removed from the tissue, it was noticed that no energy was delivered to the tissue and no seal was formed.The tissue was bleeding from where the blade lever transected the tissue.The surgeon opened up a second device to control the bleed but it also did not deliver energy to the tissue.A third device was opened which worked successfully.With this device the surgeon was able to control the bleed and complete the case.The products are not available for return.They were discarded by the facility.Additional information received via email on 04mar2020 from [applied medical representative], entered by [applied medical representative]."after visiting the account today i discovered that they did hold the devices to be sent back for examination." additional information received via email on 19mar2020 from [applied medical representative].(entered by [applied medical representative]).The rep was able to speak to the surgeon about both cases."the only thing he mentioned that was different than what the nurses in the room told me is that he heard an audible click in the hand piece before the unit stopped working.This happened for both hand pieces that were returned." patient status: no patient injury.Type of intervention: a third device was used to control the bleeding and complete the case.
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 no energy output could not be confirmed, as the event unit met current specifications and there were no visible non-conformances.Applied medical is unable to determine the exact root 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.
Event or Problem Description
Name of procedure being performed: colon procedure two complaints have been created from this report.Complaint # (b)(4) (1 out of 2).Complaint # (b)(4) (2 out of 2).Limited information available at this time.The rep was not present during the case.The jaws of the device was placed on the tissue, and the fuse activation button was activated.The generator went through the full seal tones, including the end tone.The surgeon then cut the tissue with the blade lever.When the jaws were removed from the tissue, it was noticed that no energy was delivered to the tissue and no seal was formed.The tissue was bleeding from where the blade lever transected the tissue.The surgeon opened up a second device to control the bleed but it also did not deliver energy to the tissue.A third device was opened which worked successfully.With this device the surgeon was able to control the bleed and complete the case.The products are not available for return.They were discarded by the facility.Additional information received via email on 04mar2020 from [applied medical representative], entered by [applied medical representative]."after visiting the account today i discovered that they did hold the devices to be sent back for examination." additional information received via email on 19mar2020 from [applied medical representative] (entered by [applied medical representative]).The rep was able to speak to the surgeon about both cases."the only thing he mentioned that was different than what the nurses in the room told me is that he heard an audible click in the hand piece before the unit stopped working.This happened for both hand pieces that were returned." patient status: no patient injury.Type of intervention: a third device was used to control the bleeding and complete the case.

• Brand Name: EB015, VOYANT MARYLAND FUSION 37CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9873936
• Report Number: 2027111-2020-00436
• Device Sequence Number: 18981662
• Product Code: GEI
• UDI-Device Identifier: 00607915136956
• UDI-Public: (01)00607915136956(17)210326(30)01(10)1367822
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K182653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 03/26/2021
• Device Model Number: EB015
• Device Catalogue Number: 101471081
• Device Lot Number: 1367822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VOYANT GEN 1 GENERATOR; VOYANT GEN 1 GENERATOR