ATEC INTRODUCER LOCALIZATION SET SURESIGHT
Received Sep 9, 2016 · Event occurred Aug 5, 2016
Report 1222780-2016-00225 · MDR key 5939320
Device
Generic name
Surgical Needle Guide
Manufacturer
Hologic, IncModel number
0914-20-OBCatalog number
ILS 0914-20-OB
Lot number
604558
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. 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).
Description of Event or Problem
IT WAS REPORTED DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2016, THE OBTURATOR TIP BROKE OFF INSIDE THE GRID OUTSIDE THE PATIENT. A SECOND DEVICE COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED.