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	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience.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: "laparoscopic supracervical hysterectomy." "locking mechanism on handle wasn't working." additional information was received via email from territory manager, on friday 9feb2018 at 9:44 am "locking mechanism on device was malfunctioning.The blade lever was not still engaged when surgeon was attempting to unlatch it.After getting it unlatched, the doctor was then unable to lock the handle move forward.It was used for approx 6-7 activations before they opened another eb010.The remainder of the surgery was performed successfully with the second device.Patient is ok." additional information was received via email from territory manager on tuesday 13feb2018 at 9:15 am."correct, the awareness date and the incident date are (b)(6) 2018." patient status: "patient is ok.".

• 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: 7313671
• Report Number: 2027111-2018-00097
• Device Sequence Number: 19331500
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)181219(30)01(10)1299578
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141288
• 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
• Report Date (Section B): 03/05/2018

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: Physician
• Device Expiration Date: 12/19/2018
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1299578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/05/2018
• Patient Sequence Number: 1