MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB030, VOYANT FINE FUSION, 6/BX; GEI

Model Number	EB030
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: intervention on hemorrhoids.Yes, i had the opportunity to use the device for surgery on hemorrhoids.The operation went well, in an extremely simple way.Unfortunately the patient returned 8 days later for bleeding.That said, i do not question the material at all and i would like to continue to be able to use it.Additional information received from the sales rep by email on 21mar19: surgeon recently tried voyant eb030 on hemorrhoids with milligan morgan technic.As written, procedure went well and handpiece was easy to use.However 8days later, patient came back for bleeding.Dr doesn't incriminate (question) the technology nor the device.He'd like to try again.Additional information received from the sales rep by email on 8apr19: patient status is fine.Patient status: patient status is fine.
Event or Problem Description
Procedure performed: intervention on hemorrhoids yes i had the opportunity to use the device for surgery on hemorrhoids.The operation went well, in an extremely simple way.Unfortunately the patient returned 8 days later for bleeding.That said, i do not question the material at all and i would like to continue to be able to use it.Additional information received from the sales rep by email on 21mar19: surgeon recently tried voyant eb030 on hemorrhoids with milligan morgan technic.As written, procedure went well and handpiece was easy to use.However 8days later, patient came back for bleeding.Dr doesn't incriminate (question) the technology nor the device.He'd like to try again.Additional information received from the sales rep by email on 8apr19: patient status is fine.Additional information received from the sales rep by email on 18apr19: the surgeon did a suture with thread patient status: patient status is fine.
Additional Manufacturer Narrative
Investigation summary: 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: EB030, VOYANT FINE FUSION, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8520664
• Report Number: 2027111-2019-00425
• Device Sequence Number: 16522747
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)200228(30)01(10)1335643
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153017
• 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): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1335643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization