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 2016-06-08 for ATEC INTRODUCER LOCALIZATION SET SURESIGHT 0914-20-OB ILS 0914-20-OB manufactured by Hologic, Inc.

Event Text Entries

[48057302] The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. 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


[48057303] It was reported during a breast biopsy procedure on (b)(6) 2016, the obturator "tip broke off" inside the sheath prior to inserting into the patient. The procedure was completed with a second device. "no report of patient injury".
Patient Sequence No: 1, Text Type: D, B5


[51527724] The returned device was received and visually inspected. The investigator verified that the distal tip of the obturator is broken. Cause is presently unknown for failure. The reported observation was confirmed. This observation is being trended and monitored.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222780-2016-00142
MDR Report Key5706553
Date Received2016-06-08
Date of Report2016-05-12
Date of Event2016-05-10
Date Mfgr Received2016-06-23
Device Manufacturer Date2016-04-28
Date Added to Maude2016-06-08
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 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 Report3

Device Details

Brand NameATEC INTRODUCER LOCALIZATION SET SURESIGHT
Generic NameSURGICAL NEEDLE GUIDE
Product CodeGDF
Date Received2016-06-08
Returned To Mfg2016-06-23
Model Number0914-20-OB
Catalog NumberILS 0914-20-OB
Lot Number604558
Device Expiration Date2016-10-08
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
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 2016-06-08

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