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

Model Number	EB010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
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.This report reflects the combined initial and final report.
Event or Problem Description
Procedure performed: unknown.The device fusion 5mm worked well for about 2 hours, but the jaws remained stuck.After several attempts, the jaws were able to reopen.The surgeon asked for a new device, which worked well (incident report document) there was no declaration to (b)(6).Additional information received from the sales rep by email on 23-april-2018: it is unknown whether the blade lever was not returning to the forward position when released.The surgeon was able to release the jaws from the tissue after several attempts by opening the device with both hands.There was no damage on the tissue.This occurred one time, with necessity to change device.This was observed between 2 and 4 hours of usage, number of activations unknown.The date of incident is (b)(6) 2017.The jaws of the device were cleaned during the procedure.Patient status: no patient injury or illness occurred associated with the complaint event.No consequence on the patient.

• 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: 7549441
• Report Number: 2027111-2018-00181
• Device Sequence Number: 284471
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190129(30)01(10)1301684
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/29/2018

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: 01/29/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1301684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1