MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT

Catalog Number	ECP0110GV
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, the equipment allegedly failed and the error 1018 was restarted but still persisted.It was further reported that when the needle was removed, the cutting area of the needle in the metal area was allegedly found to be fragmented.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: as the lot 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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2024).H11: 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.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: b5, d4 (expiry date: 12/2024), g3.H11: 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.Device not returned.
Event or Problem Description
It was reported that during a stereotaxic guided biopsy procedure through normal density tissue, when starting the aspiration, the equipment allegedly crashed with error 1018 indication on the screen and the screen remained stuck even on pressing the reset button.It was further reported that when the needle was removed, the cutting area of the needle in the metal area was allegedly found to be fragmented.There was no reported patient injury.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18281455
• Report Number: 2020394-2023-01156
• Device Sequence Number: 6264425
• Product Code: KNW
• UDI-Device Identifier: 00801741086250
• UDI-Public: (01)00801741086250
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K040842
• 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): 01/10/2024

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: ECP0110GV
• Device Lot Number: VTGZG002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown