MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB015, VOYANT MARYLAND FUSION 37CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB015
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
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: resektion rectum ca / rectum resection first test with eb015 in neuruppin- with oa dr.[name], i was in the operating room (or) and had explained the devices.After app.1,5 hours of use of eb 015 in the procedure, the handpiece could not be opened anymore.Tissue was in the device and the device was hanging on the tissue.Several attempts to open the branches failed, the surgeon needed to cut the branches out of the device.It was only fatty tissue - not vessels.Afterwards a second handpiece was opened - see another cer neuruppin 2.Additional information received from sales representative by email on 17may2019: the handle was locked ,sticked - no bleeding.The surgeons did not seal several times, he only wanted to open the handle and branches.It was locked.The device had been used 1,5 hours, app.60-80 activations.Cleaning was 6¿8 times.The surgeon did not notice an improvement when the jaws were cleaned.No liquid or lubricant solution was applied to the jaws.It was not visible where along the jaws the tissue stuck.The jaws were not submerged in fluid.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given any anti-coagulation medicine.Patient status: the procedure went normally with another device.Intervention: change of device.
Event or Problem Description
Procedure performed: "resection" rectum ca / rectum resection.First test with eb015 in neuruppin- with oa dr.[name], i was in the operating room and had explained the devices.After app.1,5 hours of use of eb 015 in the procedure, the handpiece could not be opened anymore.Tissue was in the device and the device was hanging on the tissue.Several attempts to open the branches failed, the surgeon needed to cut the branches out of the device.It was only fatty tissue - not vessels afterwards a second handpiece was opened - see another cer neuruppin 2.Additional information received from sales representative by email on 17may2019: the handle was locked ,sticked - no bleeding.The surgeons did not seal several times, he only wanted to open the handle and branches.It was locked.The device had been used 1,5 hours, app.60-80 activations.Cleaning was 6¿8 times.The surgeon did not notice an improvement when the jaws were cleaned.No liquid or lubricant solution was applied to the jaws.It was not visible where along the jaws the tissue stuck.The jaws were not submerged in fluid.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given any anti-coagulation medicine.Patient status: the procedure went normally with another device.Intervention: change of device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the 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, it is likely that 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: EB015, VOYANT MARYLAND FUSION 37CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8689503
• Report Number: 2027111-2019-00475
• Device Sequence Number: 2359342
• Product Code: GEI
• UDI-Device Identifier: 00607915136956
• UDI-Public: (01)00607915136956(17)200916(30)01(10)1351176
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182653
• 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): 08/02/2019

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: 09/16/2020
• Device Model Number: EB015
• Device Catalogue Number: 101471081
• Device Lot Number: 1351176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/02/2019
• Patient Sequence Number: 1