SPIDER FLEXIBLE CLIP APPLIER
Received Nov 8, 2012 · Event occurred Apr 4, 2012
Report 3007593944-2012-00009 · MDR key 2844263
Device
Generic name
Laparoscopic, General & Plastic Surgery
Manufacturer
Transenterix Inc.Model number
9000029Catalog number
9000029
Lot number
DC061121R
Product problems
- Nonstandard Device
- Difficult to Open or Close
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING AN ABDOMINAL LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE SURGICAL SALES REPRESENTATIVE INDICATED THAT THE CLIP APPLIER HAD DIFFICULTY CLOSING CLIPS. THE CLIP APPLIER WAS REMOVED FROM THE PROCEDURE AND A NEW APPLIER WAS USED. THE REPLACEMENT WORKED APPROPRIATELY.
Additional Manufacturer Narrative
UPON INVESTIGATION OF COMPLAINTS RELATED TO CLIP APPLIER FUNCTIONALITY, A NON-SAFETY RELATED QUALITY ISSUE WAS IDENTIFIED. THE DECISION WAS MADE TO RECALL THE CLIP APPLIER PRODUCT AND A RECALL WAS EXECUTED ON (B)(4) 2012. FDA WAS NOTIFIED ON (B)(4) 2012. (B)(4). DURING THE RECALL CLOSURE AND IN DISCUSSIONS WITH FDA ON (B)(4) 2012, IT WAS DETERMINED THAT MDRS SHOULD BE FILED TO ENSURE COMPLETE DOCUMENTATION. THIS MDR IS BEING FILED RETROSPECTIVELY.
Remedial action
- Recall