MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FOOT PEDAL; REUSABLE BIOPSY

Catalog Number	FSENCOR01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 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.D2b (gei; knw).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 a reusable biopsy procedure through encor enspire system, it was reported that during a stereotactic vertical approach procedure while in "sample" mode and they have already begun to sample the patient tissue, the encor enspire system suddenly reverted back to the "start calibration" screen.The user has to remove the needle to recalibrate and re-enter the tissue to complete the procedure.This occurred twice.It was identified that encor enspire system sn (b)(6), (work order-(b)(4)), encor driver sn unk (work order-(b)(4)) and encor foot pedal sn unk, (work order-(b)(4)) were used together as a system during this event.There was no patient injury.
Event or Problem Description
A patient underwent a reusable biopsy procedure through encor enspire system, it was reported that during a stereotactic vertical approach procedure while in "sample" mode and they have already begun to sample the patient tissue, the encor enspire system suddenly reverted back to the "start calibration" screen.The user has to remove the needle to recalibrate and re enter the tissue to complete the procedure.This occurred twice.It was identified that encor enspire system sn (b)(6) (wo-(b)(4), encor driver sn unk (wo-(b)(4) and encor foot pedal sn unk (wo-(b)(4) were used together as a system during this event.There was no patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the device was not returned.Investigation summary: the physical device was not returned for evaluation.No photos or video were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported device screen reverted back to calibration mode issue could not be determined based upon the provided information.Labeling review: the labelling/packaging review was not required as the reported event is not associated with a labelling, packaging, or use related issue.B5, g3, h6 (method).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.

• Brand Name: ENCOR FOOT PEDAL
• Common Device Name: REUSABLE BIOPSY
• 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: 23825498
• Report Number: 2020394-2025-02188
• Device Sequence Number: 17391662
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: FSENCOR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female