ATEC INTRODUCER LOCALIZATION SET SURESIGHT 0914-20-OB ILS 0914-20-OB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for ATEC INTRODUCER LOCALIZATION SET SURESIGHT 0914-20-OB ILS 0914-20-OB manufactured by Hologic, Inc.

Event Text Entries

[49393337] The device was received and visually inspected. The investigator verified that the obturator is broken. The distal tip of the obturator was not returned. The reported observation was confirmed. This observation is being trended and monitored. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Currently unable to establish a relationship or impact to the reported observation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[49393338] It was reported during a breast biopsy procedure (exact date unknown) the obturator tip fell off into the patient's breast. The procedure was completed with a second device. It is unknown if intervention was required. We have been unable to obtain additional information surrounding this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2016-00170
MDR Report Key5764592
Date Received2016-07-01
Date of Report2016-06-03
Date Mfgr Received2016-06-03
Device Manufacturer Date2016-02-05
Date Added to Maude2016-07-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SIDRA PIRACHA
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638884
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameATEC INTRODUCER LOCALIZATION SET SURESIGHT
Generic NameSURGICAL NEEDLE GUIDE
Product CodeGDF
Date Received2016-07-01
Returned To Mfg2016-06-27
Model Number0914-20-OB
Catalog NumberILS 0914-20-OB
Lot Number602503
Device Expiration Date2016-07-19
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-01

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