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)
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: sleeve gastrectomy."during the sleeve gastrectomy case, while the surgeon was in the process of stomach mobilization the 5mm fusion voyant device didn't work properly.The handle got stuck in place after the surgeon grasped the tissue emitting a strange noise and couldn't be released anymore.To resolve this issue, the surgeon had to use another bipolar device to separate the stuck tissue and to remove the voyant.We have the sample defective, please advice.Normal status (healthy patient) - doing sleeve gastrectomy.Procedure was completed with competitor device 5 mm ligasure convidien.Standard laparoscopic technique.Applied medical trocar 3( 5mm optical ), 1( 11mm optical) (15mm optical).No pictures available, the device is with us.Thank you" patient status: no patient injury or illness associated with complaint event.Intervention: competitor device.
Event or Problem Description
Procedure performed: sleeve gastrectomy."during the sleeve gastrectomy case, while the surgeon was in the process of stomach mobilization the 5mm fusion voyant device didn't work properly.The handle got stuck in place after the surgeon grasped the tissue emitting a strange noise and couldn't be released anymore.To resolve this issue, the surgeon had to use another bipolar device to separate the stuck tissue and to remove the voyant.We have the sample defective, please advice.Normal status (healthy patient) - doing sleeve gratrectomy.Procedure was completed with competitor device 5 mm ligasure convidien.Standard laparoscopic technique.Applied medical trocar 3( 5mm optical ), 1( 11mm optical) (15mm optical).No pictures available, the device is with us.Thank you".Patient status: no patient injury or illness associated with complaint event.Intervention: competitor device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that complainant¿s experience of a locked handle.Engineering observed that the trigger lock, a metal component located at the bottom of the trigger, was bent.Based on the condition of the returned unit, 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.

• 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: 8656173
• Report Number: 2027111-2019-00459
• Device Sequence Number: 2274537
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)190211(30)01(10)1303414
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 02/11/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1303414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1