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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT Back to Search Results
Catalog Number E4115
Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the serial number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
 
Event Description
It was reported that during a breast biopsy, the control module screen allegedly went blank during the procedure.Reportedly, the needle was taken out of the breast, the system was turned off and on several times, and the monitor attachments were disconnected and reattached them, however the issue was not resolved.The procedure was terminated and rescheduled.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: 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 enspire monitor was returned to the manufacturing site for service and repair.The encor system was not returned.The returned monitor was installed onto a service department encor enspire system for testing.The monitor was powered on and off multiple times.However, the monitor failed to boot properly and displayed a black screen due to an identified internal hardware failure.An attempt was made to reload software, however the software reload was unsuccessful due to the identified internal hardware failure of the monitor.The returned monitor was unable to be serviced, therefore scrapped.A request for a replacement monitor was issued for the customer.Per wo-00002020, the encor enspire monitor was returned for service and repair.The entire system was not returned.The returned monitor failed to boot up properly, displaying a black screen.An attempt to reload software was conducted, however unsuccessful due to an identified internal hardware failure within the monitor.Although the identified internal hardware failure contributed to the reported blank screen, the definitive root cause for the identified internal hardware failure could not be determined based upon the provided information.Per the manufacturing review, the beijer monitor assembly used within the returned monitor was retired from active production and therefore replaced with the novakon monitor assembly.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(6) (b)(6) 2018.(device code: 1183).H11:section a through f - the information provided by bard 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 bard.
 
Event Description
It was reported that during a breast biopsy, the control module screen allegedly went blank during the procedure.Reportedly, the needle was taken out of the breast, the system was turned off and on several times, and the monitor attachments were disconnected and reattached them, however the issue was not resolved.The procedure was terminated and rescheduled.There was no reported patient injury.
 
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Brand Name
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7551339
MDR Text Key109487635
Report Number2020394-2018-00744
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741086113
UDI-Public00801741086113
Combination Product (y/n)N
PMA/PMN Number
K111100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE4115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2018
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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