MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; BIOPSY INSTRUMENT

Catalog Number	DRENCOR
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the serial number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the encor driver is without force to rotate the needle, produced an error during the time examination.It was further reported that the additional information was provided during two separate sampling procedures.Reportedly, the encor enspire system emitted an error sound and returned to the needle calibration screen without displaying an error message.Furthermore, all consumables were exchanged between these procedures.It was possible to complete the procedure with the change of driver.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor driver serial number (b)(6) was received at the bard brasil ind e com ltda.The encor driver was visually inspected upon receipt and was found to be without dirt or contaminants.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported driver error issue.The root cause for reported device error issue cannot be determined as the problem could not be reproduced.Labelling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.G3, h6 (method, result, conclusion).Section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the encor driver is without force to rotate the needle, produced an error during the time examination.It was further reported that the additional information was provided during two separate sampling procedures.Reportedly, the encor enspire system emitted an error sound and returned to the needle calibration screen without displaying an error message.Furthermore, all consumables were exchanged between these procedures.It was possible to complete the procedure with the change of driver.There was no reported patient injury.

• Brand Name: ENCOR DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21966804
• Report Number: 2020394-2025-00673
• Device Sequence Number: 8691864
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076(17)461019
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 Catalogue Number: DRENCOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown