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

Model Number	ECP0112G
Medical Device Problem Codes	Filling Problem (1233); Suction Problem (2170); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one encor biopsy probe were returned for evaluation.During visual evaluation, the probe appeared clean and no other anomalies were noted on the device.It was noted that foreign material appeared on the trocar tip.An encor enspire system and in-house saline cap were used for functional testing.Upon functional testing, the probe was loaded into the driver and calibrated successfully.The probe passed in maximum vacuum test and failed in vacuum differential test.The probe was inserted into a piece of beef and around the clock sampling was performed.The probe was able to obtain 6 samples successfully.Therefore, the investigation is confirmed for the reported foreign material and identified filling issue as foreign material was found on the trocar tip and the probe fails to meet the requirement of vacuum differential test.However, the investigation is unconfirmed for the reported suction issue as the device meets the requirement of maximum vacuum test.A definitive root cause for the alleged suction issue, foreign material and identified filling issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 09/2021).
Event or Problem Description
It was reported that during a preparation for a breast biopsy, the device was allegedly had a suction issue.There was no patient contact.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• MDR Report Key: 12202207
• Report Number: 2020394-2021-01360
• Device Sequence Number: 5061828
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051158
• 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
• Report Date (Section B): 06/26/2021

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: ECP0112G
• Device Catalogue Number: ECP0112G
• Device Lot Number: VTDW0659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/21/2021
• 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