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

Catalog Number	E5115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sampling was conducted without pushing sample button.Replaced a probe with another, and procedure was completed.It was further reported that the issue occurred during sampling.When the opener was closed, disconnected the needle and replaced with another needle.Then procedure was completed.No error messages were displayed.A patient was involved, however there was no injury reported.
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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 sampling was conducted without pushing sample button.Replaced a probe with another, and procedure was completed.It was further reported that the issue occurred during sampling.When the opener was closed, disconnected the needle and replaced with another needle.Then procedure was completed.No error messages were displayed.A patient was involved, however there was no injury reported.
Additional Manufacturer Narrative
H11: 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 ultra serial number (b)(6) was received at the medicon inc.The encor ultra was visually inspected upon receipt and no physical damage was found to the unit.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device sampling on its own issue.The root cause for reported device sampling on its own 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.G3, h3, h6 (method, result, conclusion).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.

• Brand Name: ENCOR ENSPIRE SYSTEM
• 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: 21888163
• Report Number: 2020394-2025-00608
• Device Sequence Number: 3434929
• Product Code: KNW
• UDI-Device Identifier: 00801741086137
• UDI-Public: (01)00801741086137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111100
• 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): 06/20/2025

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 Catalogue Number: E5115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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