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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTEM; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTEM; BIOPSY INSTRUMENT Back to Search Results
Model Number E4115
Medical Device Problem Code Application Program Problem (2880)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is unconfirmed for application program problem.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model e4115 biopsy instrument allegedly experienced application program problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.
 
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Brand Name
ENCOR ENSPIRE SYSTEM
Common Device Name
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10763895
Report Number2020394-2020-06374
Device Sequence Number1128534
Product Code KNW
UDI-Device Identifier00801741086113
UDI-Public(01)00801741086113
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/30/2020
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 No Information
Device Model NumberE4115
Device Catalogue NumberE4115
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/30/2020
Patient Sequence Number1
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