MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTM 115V; BIOPSY INSTRUMENT

Model Number	E4115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2045).
Event or Problem Description
It was reported that during a vacuum assisted breast biopsy procedure, the device allegedly had unintended cutting sequence inside the patient.There was no reported patient injury.
Event or Problem Description
It was reported that during a vacuum assisted breast biopsy procedure, the device allegedly had unintended cutting sequence inside the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues, therefore a device history record and a manufacturing review are not required.Investigation summary: the device was received for evaluation.The enspire was visually inspected upon receipt and was found to be in good condition.The device was tested and investigation has been determined to be unconfirmed for the reported device unintended cutting sequence inside the patient.The root cause cannot be determined as the problem could not be reproduced.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 02/2045).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.

• Brand Name: ENCOR ENSPIRE SYSTM 115V
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10941056
• Report Number: 2020394-2020-20722
• Device Sequence Number: 3234676
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: E4115
• Device Catalogue Number: E4115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other