MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB216
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: no information.Detailed description of event: the rep was not present during the case.The device packaging was opened and within the package the surgical team found a hair wrapped up in the prongs of the device key.The device was not used in the case and another voyant was opened and used in the case.No patient impact.Product is available for return.Additional information received via email on 23sep2021 from [name], applied medical account manager iii: photos of the product and the hair has been provided.Patient status: no patient impact.Type of intervention: used new device to complete case.
Event or Problem Description
Name of procedure being performed: no information.Detailed description of event: the rep was not present during the case.The device packaging was opened and within the package the surgical team found a hair wrapped up in the prongs of the device key.The device was not used in the case and another voyant was opened and used in the case.No patient impact.Product is available for return.Additional information received via email on 23sep2021 from [name], applied medical account manager iii: photos of the product and the hair has been provided.Patient status: no patient impact.Type of intervention: used new device to complete case.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair, the hair was taped to the device key.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12624244
• Report Number: 2027111-2021-00664
• Device Sequence Number: 3451940
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)240714(30)01(10)1421066
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 07/14/2024
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1421066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown