MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the blade remained in the lower jaw of the device.Engineering disassembled the event unit and observed that the blade pusher, an internal component of the device, was damaged.Based on the condition of the returned unit, the reported event was caused by the damaged blade pusher.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: hysterectomy non robotic.Event description: after approximately 5 to 10 activations and cuts the blade became stuck while cutting.The surgeon pulled out the device through the trocar and grasped the blade lever and the blade stuck out to the end of the jaw and would not retract when the surgeon squeezed the trigger.The surgeon was cutting a fallopian tube when he noticed the stuck blade.The device was replaced with a new applied medical device and the case continued with no further concerns.The device was not cleaned prior to the surgeon noticing the stuck blade.No patient injury occurred.The device is available for return.The rep was present for the case.Type of intervention: the device was replaced with a new applied medical device and the case continued with no further concerns.Patient status: no patient injury occurred as a result of the complaint event.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9416879
• Report Number: 2027111-2019-00645
• Device Sequence Number: 16572020
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)201128(30)01(10)1358494
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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

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: 11/28/2020
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1358494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1