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

Catalog Number	DRENCOR
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2046.) 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.
Event or Problem Description
It was reported that during a biopsy procedure, while using anesthetic mode, the device performed four biopsies and system allegedly started taking samples on its own without pressing any sample buttons on either the foot pedal or driver.It was further reported that the device allegedly continued to sample when out of the patient's breast even when the stop pedal was deployed.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, while using anesthetic mode, the device performed four biopsies and system allegedly started taking samples on its own without pressing any sample buttons on either the foot pedal or driver.It was further reported that the device allegedly continued to sample when out of the patient's breast even when the stop pedal was deployed.The procedure was not completed.There was no reported patient injury.
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: the encor driver serial number was received for evaluation.The encor driver was visually inspected upon receipt and no damage was found to the unit and system functions normally.The device was functionally tested and passed the test identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device continued to sample when out of the patient's breast even when the stop pedal was deployed issue.The root cause for reported device continued to sample when out of the patient's breast even when the stop pedal was deployed 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: b5, d4 expiration date: 12/2046.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.

• Brand Name: ENCOR DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• 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: 19768168
• Report Number: 2020394-2024-01060
• Device Sequence Number: 8479174
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: DRENCOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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