MalfunctionDWH
BOOKWALTER RET ML BL 3X6
Received Dec 2, 2010 · Event occurred Sep 16, 2010
Report 1226348-2010-00395 · MDR key 1937806
Device
Generic name
Retractors
Manufacturer
Codman & Shurtleff, Inc.Model number
NACatalog number
50-4567
Lot number
093
Product problems
- Break
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- No Consequences Or Impact To Patient
- Surgical procedure, delayed
Narrative
Description of Event or Problem
AFFILIATE REPORTED THAT THE BLADE BROKE OFF THE HANDLE DURING USE IN A GASTRIC OPERATION. IT WAS REPORTED THAT THE BLADES WERE RECOVERED, HOWEVER, AS A RESULT, SURGERY WAS DELAYED.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.