ATEC INTRODUCER LOCALIZATION SET SURESIGHT
Received Apr 1, 2016 · Event occurred Jan 4, 2016
Report 1222780-2016-00078 · MDR key 5542734
Device
Generic name
Surgical Needle Guide
Manufacturer
Hologic, IncModel number
0914-20-OBCatalog number
ILS 0914-20-OB
Lot number
509594
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. WE ARE CURRENTLY IN THE PROCESS OF EVALUATING THE DEVICE AND WILL SEND A SUPPLEMENT REPORT WHEN COMPLETED. (B)(4).
Description of Event or Problem
IT WAS REPORTED COMPONENTS WERE LOOSE INSIDE THE ATEC-SURESIGHT UNOPENED PACKAGE.
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.