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	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering observed that the blade was exposed.The unit was disassembled and engineering observed that the blade pusher, an internal component of the device, was damaged.Based on the condition of the returned unit, the event unit was unable to cut due to the damaged blade pusher.Applied medical is unable to determine the root cause of the damage to the blade pusher based on the evaluation of the returned unit.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: unknown.Event description: when the dr.Try to cut, the voyant didn´t cut during all surgery.Additional information received by email from applied medical representative on 04feb20: total laparoscopic hysterectomy.The surgeon told me about 5 cut, he saw that voyant didn´t cut anything.He didn´t told me this¿he don¿t remember¿but i know that in this surgeries there are a lot of connective tissue.He told me that he had resistance.The voyant didn't cut anything.The surgeon did not notice any improvement if/when the jaws were cleaned.The surgeon was not able to find a resolution, he changed the handpiece.Patient status: patient is well.

• 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: 9935675
• Report Number: 2027111-2020-00448
• Device Sequence Number: 16768597
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)201119(30)01(10)1358479
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193292
• 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): 04/07/2020

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: 11/19/2020
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1358479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR