MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB011, VOYANT 5MM FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB011
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit and the complainant's experience of unintended rf output could not be replicated.When the event unit was disassembled, dried blood and eschar was observed on the internal components of the handle.Based on the condition of the returned unit, the reported event was most likely caused by fluid ingress into the handle that occurred when the device was held at an acute angle and the jaws are submerged in fluid.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report represents a combined initial/follow-up report.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy converted open.Event description: rep.Was present for the case.He stated that it was a long case that started at 9:00 am.The voyant eb011 handpiece was used for around 4 hours.Around the 4 hour mark, which was the last time it was used, the "re-activate device" error appeared.After the 10th/11th attempt to re-activate the device, it managed to complete 1 seal cycle.After this, the device was set aside since it was the last time the surgeon needed to use the handpiece (per the rep., the doctor switched to using monopolar since advanced bipolar was no longer needed).1 hour later after the device had been set aside, the rep.Noticed that the handpiece had miraculously decided to activate on its own with the jaws open - it even managed to complete 1 seal cycle.It actually went through seal cycles 4 times before being unplugged by the rep.After it was unplugged and then re-plugged back in by the rep, the handpiece, once again, went through 1 seal cycle.All seal cycles happened outside the patient (i.E.No patient contact) since it was after use.The product is available for return and there was no patient injury.Type of intervention: continued the case without advanced bipolar since it was no longer needed.Patient status: no patient injury occurred.

• Brand Name: EB011, VOYANT 5MM 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
• MDR Report Key: 9293838
• Report Number: 2027111-2019-00628
• Device Sequence Number: 19445004
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)201121(30)01(10)1358511
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172624
• 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

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: 11/21/2020
• Device Model Number: EB011
• Device Catalogue Number: 101427001
• Device Lot Number: 1358511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1