MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB011, VOYANT 5MM FUSION 44CM, 6/BX; GEI

Model Number	EB011
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: sigma resection / sigmoid resection.During preparation and sealing due to industries did not close anymore and the blade moved from the outside visible to the front.Additional information received from sales representative via phone on 22jan2019: after about an hour, an hour and a half, there was a cracking noise from the handpiece when the surgeon was doing the preparation of the tissue.After this, the jaws wouldn¿t close anymore.The blade could be advanced with the jaws open.The handpiece was exchanged for another and the surgery could be finished without issues.Patient status: no patient injury or illness occur associated with the complaint event.Intervention: change of device.
Event or Problem Description
Procedure performed: sigma resection sigmoid resection.During preparation and sealing due to industries did not close anymore and the blade moved from the outside visible to the front.Additional information received from sales representative via phone on (b)(6) 2019: after about an hour, an hour and a half, there was a cracking noise from the handpiece when the surgeon was doing the preparation of the tissue.After this, the jaws wouldn¿t close anymore.The blade could be advanced with the jaws open.The handpiece was exchanged for another and the surgery could be finished without issues.Patient status: no patient injury or illness occur associated with the complaint event.Intervention: change of device.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: EB011, VOYANT 5MM FUSION 44CM, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8344728
• Report Number: 2027111-2019-00349
• Device Sequence Number: 11099247
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)200229(30)01(10)1335438
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172624
• 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,Followup
• Report Date (Section B): 03/19/2019

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: 02/29/2020
• Device Model Number: EB011
• Device Catalogue Number: 101427001
• Device Lot Number: 1335438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1