MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCE CORPORATION VOYANT MARYLAND FUSION DEVICE

Model Number 1003229F

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

Voyant maryland disposable device utilized for a tubal ligation, d&c and ablation procedure.Initially worked properly then displayed an error code which could not be cleared.The device was removed and a second device open and used which functioned properly.

• Brand Name: VOYANT MARYLAND FUSION DEVICE
• Type of Device: MARYLAND FUSION DEVICE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCE CORPORATION; ranch sant margarita CA
• MDR Report Key: 18468161
• MDR Text Key: 332397308
• Report Number: 18468161
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1003229F
• Device Catalogue Number: EB215 5MM X 37CM
• Device Lot Number: 1442979
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2022
• Distributor Facility Aware Date: 05/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White