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

Model Number	FSENCOR01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, while trying to deploy the marker, the system took two further samples without pressing/selecting anything on the encor system, driver or foot pedal.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a device history record 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 foot pedal was received at the bard medical south africa.The encor foot pedal was visually inspected upon receipt and was found to be free from defects and all labeling is legible.The device was functionally tested and passed all the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported system took two further samples without pressing/selecting anything on the encor foot pedal.The root cause for the reported system took two further samples without pressing/selecting anything on the encor foot pedal cannot be determined as the problem could not be reproduced.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 12/2050).

• Brand Name: ENCOR FOOT PEDAL
• Common Device Name: REUSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 16483387
• Report Number: 2020394-2023-00137
• Device Sequence Number: 5263400
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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 Model Number: FSENCOR01
• Device Catalogue Number: FSENCOR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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