ENCOR BIOPSY PROBE ECP017G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for ENCOR BIOPSY PROBE ECP017G manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[185280073] A customer notification was issued for the encor breast biopsy probe for specific product code/lot number combinations. The affected product code/lot number combinations may be at risk of experiencing a leak between the probe and the tissue collection chamber, which could result in minimal suction, leakage, minimal or no tissue sample obtained, or an egress of fluids from the device. A root cause investigation and field action determination was conducted as a result of an increase in complaints for leaks, suction issues, and failure to obtain samples. The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices. The investigation identified that one of the features on the trap chamber was under specified and during the implementation of a new trap chamber ((b)(4)) mold, one of the dimensions changed and went undetected, creating a difference between the amount of space that the seal has between the trap chamber and the front seal cap. This gap between the trap chamber and front seal cap resulted in conditions that led to a higher likelihood of leaks, suction issues, and failure to obtain samples. All reported complaints from the affected product code/lot number combinations that are possibly related to the gap between the trap chamber and front seal cap have been classified as leak, suction issues), or failure to obtain samples. This reported complaint is from an affected lot number that was reported for one of these trap chamber issues. (expiry date 10/2020), (device component code: (b)(4)).
Patient Sequence No: 1, Text Type: N, H10


[185280154] It was reported that during an ultrasound guided breast biopsy through calcified tissue, device allegedly had a suction issue. The procedure was completed using another device. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-02141
MDR Report Key9890009
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-12
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1INFUS MEDICAL (THAILAND)
Manufacturer Street706 MOO 4 BANGPOO IND ESTATE
Manufacturer CitySAMUTPRAKARN PROVINCE 10280
Manufacturer CountryTH
Manufacturer Postal Code10280
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction NumberZ-2211-2019
Event Type3
Type of Report3

Device Details

Brand NameENCOR BIOPSY PROBE
Generic NameBIOPSY INSTRUMENT
Product CodeKNW
Date Received2020-03-27
Model NumberECP017G
Catalog NumberECP017G
Lot NumberVTCX0488
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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