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	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A 66-year-old female patient underwent a stereotactic breast biopsy procedure using the encor enspire system.During the procedure, encor enspire system unexpectedly entered into reboot mode while the needle was inside the patient's breast.The procedure was performed in an upright position using vertical approach at the cc angle.No buttons were pressed on the encor foot pedal or the encor driver.While the needle was in the patient's breast and the radiologist was preparing to administer additional lidocaine, the technologist believes the radiologist moved the cables out of the way by the needle.Then, the encor enspire system's screen switched to a reboot mode.So, the technologist powered off the encor enspire system and instructed the radiologist to remove the lidocaine syringe and withdraw the needle.Furthermore, the technician had powered the encor enspire system back on and had to reattach the needle and recalibrate.Then, the technician attached the needle and the radiologist advanced the needle back into the patient's breast to complete the procedure.There was no reported patient injury.
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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f - the information provided by bd represents all of 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 66 year old female patient underwent a stereotactic breast biopsy procedure using the encor enspire system.During the procedure, encor enspire system unexpectedly entered into reboot mode while the needle was inside the patient's breast.The procedure was performed in an upright position using vertical approach at the cc angle.No buttons were pressed on the encor foot pedal or the encor driver.While the needle was in the patient's breast and the radiologist was preparing to administer additional lidocaine, the technologist believes the radiologist moved the cables out of the way by the needle.Then, the encor enspire system's screen switched to a reboot mode.So, the technologist powered off the encor enspire system and instructed the radiologist to remove the lidocaine syringe and withdraw the needle.Furthermore, the technician had powered the encor enspire system back on and had to reattach the needle and recalibrate.Then, the technician attached the needle and the radiologist advanced the needle back into the patient's breast to complete the procedure.There was no reported 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 switched screens reboot 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.G3, h6 (result, conclusion).Section a through f: the information provided by bd represents all of 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: 24141739
• Report Number: 2020394-2026-00021
• Device Sequence Number: 15824427
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557(17)450330
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K013641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 12/29/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/15/2026
• 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 Age: 66 YR
• Patient Sex: Female