MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; GEI

Model Number	EB010
Medical Device Problem Codes	Defective Component (2292); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Engineering observed that the trigger lock, a metal component located at the bottom of the trigger, was deformed.Based on the condition of the returned unit, it is likely that the reported event was caused by deformation of the trigger lock, which is used to engage and disengage the trigger from the handle.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented component enhancements intended to further minimize the potential for this type of event to occur.
Event or Problem Description
Procedure performed: sigmoid resection.During the intervention, after having already made 14 shots of the voyant 5mm fusion clamp, the handle remained stuck.The surgeon closed the jaws by pressing the handle, delivered the energy to seal the tissue, passed the blade and cut the tissue, but at the time of opening the handle to open the jaws was run aground.The surgeon had to finish the surgery with another clamp.After trying to unclog the clamp, jump the small metal piece that allows the handle to close and open.This piece was hooked to the handle with adhesive tape so that there is proof of which piece it is.Additional information received from sales representative by email on 06/18/2018: the blade did not get stuck.What got stuck was the handle.The surgeon was able to release the jaws from the tissue after energy delivery and tissue transection.The tissue was removed well, without tissue damage or bleeding.The surgeon found a resolution by changing the device.The hospital warehouse kept the sample so that we can pick it up.Patient status: no patient injury or illness occur associated with the complaint event.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7695820
• Report Number: 2027111-2018-00228
• Device Sequence Number: 1409985
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190208(30)01(10)1301696
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K141288
• 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): 07/17/2018

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: 02/08/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1301696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/17/2018
• Patient Sequence Number: 1