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

Catalog Number	DRENCOR
Medical Device Problem Codes	Failure to Read Input Signal (1581); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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
A patient underwent for a stereotactic mammography breast biopsy procedure using encor driver by vertical approach.It was reported that the device continued to operate without any button being pressed.Further clarification was provided that during the sampling process, the sample button on either the encor driver or the encor foot pedal failed to respond.The encor enspire system was ultimately stopped through manual intervention.There was no patient injury.During the middle of the sampling process, the encor driver continued to take samples without any user input and did not stop sampling, even without the sample button being pressed.The user was unable to stop the encor driver therefore, the user had to completely stop the encor enspire system.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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 bd/bard crawley tech services dept.The encor driver was visually inspected upon receipt and and no damage was found to the unit and the driver functions normally.The device was functionally tested and no issues identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device unintended movement issue, and the investigation is determined to be unconfirmed for the reported sample button failing to respond issue.The root cause for reported device unintended movement issue cannot be determined as the problem could not be reproduced.The root cause for reported sample button failing to respond issue cannot be determined as the problem could not be reproduced.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.G3, h6 (device, method, result, conclusion).Section a through f: the information provide 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
A patient underwent for a stereotactic mammography breast biopsy procedure using encor driver by vertical approach.It was reported that the device continued to operate without any button being pressed.Further clarification was provided that during the sampling process, the sample button on either the encor driver or the encor foot pedal failed to respond.The encor enspire system was ultimately stopped through manual intervention.There was no patient injury.During the middle of the sampling process, the encor driver continued to take samples without any user input and did not stop sampling, even without the sample button being pressed.The user was unable to stop the encor driver therefore, the user had to completely stop the encor enspire system.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: 22575296
• Report Number: 2020394-2025-01090
• Device Sequence Number: 9474166
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076(17)501231
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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