MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB030, VOYANT FINE FUSION, 6/BX; GEI

Model Number	EB030
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed- thyroidectomy: patient under previscan (objective inr 2-3).Relay 5 days before the intervention by lovenox.Total thyroidectomy on (b)(6) for goitre multi hetero nodular basedowified.Resumption of the previscan at the removal of the redons, at day 2.Surgical recovery on (b)(6) 2017 original: patient sous previscan (objectif inr 2-3).Relais 5 jours avant l'intervention par lovenox.Thyroïdectomie totale le (b)(6) pour goître multi hétéro nodulaire basedowifié.Reprise du previscan à l'ablation des redons, à j2.Reprise chirurgicale le (b)(6) 2017.Additional information received from clinical and sales rep on 12 apr 2017: before converting to the voyant fine fusion device the surgeons were using standard bipolar and sometimes clips for these surgeries.The account has been using voyant fine fusion device for roughly 3 months now.Initial event description communicated by the sales rep is describing the return of the patient to operating room after day 7.Complaint: bleeding 7 days after the surgery.Patient status:surgical recovery.
Additional Manufacturer Narrative
Investigation summary: the event product was not returned for evaluation.Based on the complainant's description of the event and additional information received, it could not be determined if a device malfunction occurred.In the absence of the subject device, it is difficult to determine the root cause of the event.Although the root cause of the event could not be determined, applied medical is currently implementing corrective actions within a corrective and preventative action report to mitigate this type of event.
Event or Problem Description
Additional information received from sales rep on 19 april 2017 : the device function normally during the procedure.There wasn't more bleeding than usual.There was no alarm tone during any of the procedure.There was not conductive fluid or blood pooling around the jaws before sealing.The nurse use to clean the devices after one or two fusion cycles - not excessive eschar on the jaws.The patient was on anticoagulant.He uses the voyant since a few months, so he makes a connection - it's difficult to know if the bleeding comes from specifically from vessels sealed with fine fusion additional information received from sales rep on 27 april 2017 : the surgeon is used to take scissors and bipolar in addition to the fine fusion voyant, for all thyroidectomy.Before using fine fusion he used some clips for the biggest vessels.

• Brand Name: EB030, VOYANT FINE FUSION, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6492358
• Report Number: 2027111-2017-01716
• Device Sequence Number: 662563
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)170614(30)01(10)1284668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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
• Operator of Device: Other
• Device Expiration Date: 06/14/2017
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1284668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 06/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention