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	12/05/2024
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: d2b (gei; knw).H11: 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
It was reported that when attaching the encor probe to the fire forward and attaching the fire forward to the mammo unit the sample started without the hcp selecting the sampling button nor stepping on the foot pedal.We could not enter the patient as the machine kept on wanting to restore vacuum and just kept on sampling until we removed the probe from the fireforward or when removing the probe and the fireforward together from the mammo unit.We tried 2 encor probes to understand if this is a probe error or a encor unit driver error.It seems to be encor unit driver error and not probe error.The two probes used has the same lot number.The incident occurred before use.There was no patient contact.
Additional Manufacturer Narrative
H10: 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: one encor foot pedal was received at the bard medical south africa.The encor foot pedal was visually inspected upon receipt and was found to be no damage on the unit.The device was functionally tested and passed the test during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported unintended movement.The root cause for reported unintended movement issue cannot be determined as the problem could not be reproduced.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: g3, h6 (method).H11: d2b (gei; knw), h6 (result, conclusion).H11: 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
It was reported that when attaching the encor probe to the fire forward and attaching the fire forward to the mammo unit the sample started without the hcp selecting the sampling button nor stepping on the foot pedal.We could not enter the patient as the machine kept on wanting to restore vacuum and just kept on sampling until we removed the probe from the fireforward or when removing the probe and the fireforward together from the mammo unit.We tried 2 encor probes to understand if this is a probe error or a encor unit driver error.It seems to be encor unit driver error and not probe error.The two probes used has the same lot number.The incident occurred before use.There was no patient contact.

• 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: 21261469
• Report Number: 2020394-2025-00031
• Device Sequence Number: 15819715
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557(17)170831
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 08/31/2017
• Device Catalogue Number: FSENCOR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/04/2025
• 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