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 Codes	Burn(s) (1757); Injury (2348)
Date of Event	02/12/2018
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, which confirmed the reported event of a stuck blade.However, the complainant's experience of "insufficient hemostasis" could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances with sealing performance.Photos received by the complainant confirmed the reported skin burns.Based on the additional information received from the complainant, it is likely that the skin burns was caused by the surgeon from improper handling of the device during use.The instructions for use (ifu) advises the user: "during device activation, keep the jaws of the device away from adjacent tissue as the jaws may remain hot enough to cause burns." it is likely that the stuck blade was caused by excessive eschar build-up within the blade channel.When the eschar was cleared from the blade channel, the unit passed subsequent blade activations.The ifu warns, "build-up of eschar can negatively affect the sealing and cutting performance." applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the root cause of the bleeding or confirm that a product malfunction occurred.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: total thyroidectomy incident description: patient: female, (b)(6), hypertension, hyperthyroidism, nicotine abuse, obesity, no anticoagulant medication, no special bleeding tendency.Surgeons used the eb030 for the total thyroidectomy.Surgeon usually uses overholts and ligatures, because other sealing devices are too expensive.The instrument was cleaned regularly during the procedure and worked reliably.Large vessels were supplied with ligatures and / or sutures, because both surgeons have good experience with this.Eb030 was used for smaller vessels and for preparation.Insertion of a 10 ch redon drainage.Wound closure.During the procedure, the surgeon touched the skin on the edge of the wound with the outside of the branch while sealing tissue, causing to burns (attached you´ll find a photo) additional points of criticism: the handpiece should be more stable, especially at the two ring handles.After activating the blade, it gets stuck sometimes.Anyway i received a positive feedback after this case (see attached the feedback form).After about 1 hour, the patient had to return into the or, as she had a lot of bleeding (roughly 400 ml).A few small veins were bleeding easily.No big, active bleeding.These veins were partially sealed with voyant eb030 in the first procedure, partially ligated.During revision, these veins were then ligated again.No use of the voyant in the second procedure.After hemostasis, insertion of 2 redon drainages (1x 10 ch, 1x 12 ch) and wound closure.Initially voyant was not blamed for the incident.After about 15 minutes, the patient had to undergo surgery for the third time because she coughed heavily in the wake-up phase, causing a re-bleeding.There was no strong, active bleeding.The surgeons supplied all the vessels again with ligatures.After hemostasis, the anesthesiologist blew the lungs several times to see if any bleeding reappeared.No visible bleeding in the situs.Insertion of two redon drainages (2x 12 ch), wound closure.In summary, the patient had to undergo surgery three times in 6 hours.Both surgeons think that voyant is the reason for this injury.Customer requests a report of the investigation.Please send the report to me.Additional information received from sales representative by phone on (b)(6) 2018: the feedback form was filled in with an excellent rating, because it was filled in straight after the initial surgery.The surgeon indicated the burns were his own fault because he touched the instrument to the tissue.The patient is currently in the icu and has been extubated.The has not been any more bleeding.The patient is stable so far.Additional information received from sales representative by email on (b)(6) 2018: according to the surgeons, during the second procedure they saw bleeding from a few small veins.These were ligated.During the third operation, they did not see any active bleeding, the bleeding was rather diffuse.There were some accidental reactivation alarms during the initial procedure.The sealing cycle was always completed before cutting the tissue.The surgeons prefer using overholts and ligatures, because they want to prevent the higher costs of an energy device.Patient status: patient had to undergo surgery 3 times in 6 hours.Burns.Update (b)(6) 2018: the patient is currently in the icu and has been extubated.The has not been any more bleeding.The patient is stable so far.

• 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: 7336492
• Report Number: 2027111-2018-00102
• Device Sequence Number: 200965
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)180426(30)01(10)1309358
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/13/2018

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: 04/26/2018
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1309358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1