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

Catalog Number	FSENCOR01
Medical Device Problem Codes	Application Program Problem (2880); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stereo procedure, the driver's probe would not close.The probe was replaced with a new needle.The driver was able to calibrate with a new probe and samples were obtained.However, the rinse button on the system's touchscreen was not appearing on the screen.Tried to restart the system, but it did not resolve the touchscreen for the rinse button issue.Additionally, it was also reported the sn on the device's label is not legible.
Additional Manufacturer Narrative
H10: as the serial number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record and manufacturing review was not required as the serial number is unknown and device was not returned.Investigation summary: the physical device was not returned for evaluation.No photos or video were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the serial number not legible/communication issue could not be determined based upon the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.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 stereo procedure, the driver's probe would not close.It was further reported that the probe was replaced with a new needle.Furthermore, the driver was able to calibrate with a new probe and samples were obtained.However, the rinse button on the system's touchscreen was not appearing on the screen.Tried to restart the system, but it allegedly did not resolve the touchscreen for the rinse button issue.Additionally, it was also reported that the serial number on the device's label allegedly not legible.There was no reported patient injury.

• Brand Name: ENCOR BREAST BIOPSY SYSTEM FOOT PEDAL
• Common Device Name: BIOPSY INSTRUMENT
• 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: 19244395
• Report Number: 2020394-2024-00597
• Device Sequence Number: 7383914
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K013641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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: FSENCOR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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