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

Catalog Number	FSENCOR01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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
It was reported that during an upright vertical stereotactic procedure, the encor driver would not stop sampling after the user removed their foot off the encor foot pedal.The encor enspire needed to be switched off to stop the driver from sampling.After the enspire was switched back on, error code 1005 (driver button or contact stuck during initialization) was displayed.The enspire was switched off before removing the needle from the patient.There was patient involvement with no injury.It was identified that the encor enspire , the encor foot pedal and the encor driver were used together as a system during this event.
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 foot switch serial number 04998 was received at the bard medical south africa.The foot switch was visually inspected upon receipt and was found to be in perfect working order.The device was functionally tested and passed all the tests during evolution.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported unintended movement issue.The root cause for reported unintended movement 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.D2b: (gei; knw), d4(unique identifier (udi) #), g2, g3, h6 (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 during an upright vertical stereotactic procedure, the encor driver would not stop sampling after the user removed their foot off the encor foot pedal.The encor enspire needed to be switched off to stop the driver from sampling.After the enspire was switched back on, error code 1005 (driver button or contact stuck during initialization) was displayed.The enspire was switched off before removing the needle from the patient.There was patient involvement with no injury.It was identified that the encor enspire, the encor foot pedal and the encor driver were used together as a system during this event.

• 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: 23307801
• Report Number: 2020394-2025-01686
• Device Sequence Number: 14906463
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557(17)210831(10)04998
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K013641
• 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): 12/22/2025

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 Expiration Date: 08/31/2021
• Device Catalogue Number: FSENCOR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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