MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB011, VOYANT 5MM FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB011
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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.This report represents a combined initial and follow-up report.
Event or Problem Description
Procedure performed: lar.Event description: rep.Wasn't present for the case, but did have a chance to speak with the surgeon after the case had been completed.Surgeon told rep.That at the beginning of the case, after 3 activations, when he tried to transect the tissue, it failed to cut.The handpiece did seal correctly, but there was no cutting.The surgeon didn't experience any resistance or difficulty when actuating the blade lever.The rep.Is unsure as to exactly what kind of tissue was being cut at the time, but stated that it was thin tissue (possibly mesentery tissue) that wasn't greater than 7 mm.The blade wasn't cutting at all and hardly any tissue had been cut when the blade was activated (percentage information was unavailable).The surgeon switched to using another eb011 to complete the case without any further issues.There was no patient injury and the product is expected to return.Type of intervention: switched to using another eb011 to complete the case without any further issues.Patient status: no patient injury occurred.

• Brand Name: EB011, VOYANT 5MM FUSION 44CM, 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: 9490800
• Report Number: 2027111-2019-00669
• Device Sequence Number: 18896814
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)201121(30)01(10)1358511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172624
• 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): 12/18/2019

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: 11/21/2020
• Device Model Number: EB011
• Device Catalogue Number: 101427001
• Device Lot Number: 1358511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1