ATEC INTRODUCER LOCALIZATION SET SURESIGHT
Received Jul 21, 2016 · Event occurred Jun 23, 2016
Report 1222780-2016-00182 · MDR key 5813092
Device
Generic name
Surgical Needle Guide
Manufacturer
Hologic, IncModel number
0914-20-OBCatalog number
ILS 0914-20-OB
Lot number
602503
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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).
Description of Event or Problem
IT WAS REPORTED DURING A BREAST BIOPSY PROCEDURE (EXACT DATE UNKNOWN) THE OBTURATOR TIP FELL OFF OUTSIDE THE PATIENT PRIOR TO INSERTION. NO REPORT OF PATIENT INJURY.
Additional Manufacturer Narrative
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.