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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTM 115V; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTM 115V; BIOPSY INSTRUMENT Back to Search Results
Model Number E4115
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/28/2021
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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2099).
 
Event or Problem Description
It was reported that post biopsy procedure, the canister was allegedly cracked.There was no reported patient injury.
 
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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 Key11371936
Report Number2020394-2021-00325
Device Sequence Number4037930
Product Code KNW
UDI-Device Identifier00801741086113
UDI-Public(01)00801741086113
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K111100
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/17/2021
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 NumberE4115
Device Catalogue NumberE4115
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2021
Initial Report FDA Received Date02/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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