MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB040, VOYANT OPEN FUSION, 6/BX; GEI

Model Number	EB040
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/27/2018
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: total abdominal hysterectomy.Incident description: this was his 4th time using the voyant handpiece.There were no alarms or misfires.Surgeon rated the device as clinically superior on the evaluation.Patient was in recovery after the surgery when it was noticed that she had low blood pressure, 70 over 40 and a pale complexion.Patient was brought back to the operating room and found blood loss of 1200cc due to a hematoma in the adnexal pedicles.Patient given blood transfusion and was fine.Rep verified that the patient had not been on steroids or blood thinners.Patient status: patient fine, given blood transfusion.Recovered well.
Event or Problem Description
Procedure performed: total abdominal hysterectomy.This was his 4th time using the voyant handpiece.There were no alarms or misfires.Surgeon rated the device as clinically superior on the evaluation.Patient was in recovery after the surgery when it was noticed that she had low blood pressure, 70 over 40 and a pale complexion.Patient was brought back to the operating room and found blood loss of 1200cc due to a hematoma in the adnexal pedicles.Patient given blood transfusion and was fine.Rep verified that the patient had not been on steroids or blood thinners.Patient status: patient fine, given blood transfusion.Recovered well.
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: EB040, VOYANT OPEN FUSION, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8017443
• Report Number: 2027111-2018-00400
• Device Sequence Number: 1755198
• Product Code: GEI
• UDI-Device Identifier: 00607915137953
• UDI-Public: (01)00607915137953(17)200914(30)01(10)1332762
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 09/14/2020
• Device Model Number: EB040
• Device Catalogue Number: 101223401
• Device Lot Number: 1332762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention