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	04/12/2018
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.This report reflects the combined initial and final report.
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy.Two surgeons performed the procedure.The first surgeon used the eb010 in the first half of the procedure without issues.The second surgeon placed tension on tissue during the seal cycle, and bleeding occurred after the jaws opened and tension was released.It appeared that eschar built up in the jaws due to stopping the bleeding.The jaws became stuck in the closed position and the surgeon had to force the handle open to release the tissue.A new eb010 was opened and the first surgeon finished the procedure without issues.There was no patient injury.Rep stated he was in the procedure.The blade lever was not being used at the time the handle became stuck in the closed position, it was only being used to seal to stop the bleeding.The jaws became stuck just one time.The device was being used under 50 activations approximately.Activation errors will appear on the device key as the surgeon stated he tapped the activation button intentionally without completing the seal cycle as a technique for using the device on non-vascular tissue.The tissue was not sticking.The handle only became stuck once and was forced open before it was replaced.Patient status: there was no patient injury.

• 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: 7557257
• Report Number: 2027111-2018-00166
• Device Sequence Number: 10831872
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190808(30)01(10)1317786
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/31/2018

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: 08/08/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1317786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1