MalfunctionOVN
DEK BL MF 0 TC-43 2N 48
Received Jul 29, 2015 · Event occurred Jun 17, 2015
Report 3004365956-2015-00199 · MDR key 4949505
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ALLEGED EVENT: THE SUTURE BROKE UP IN THE DRIVER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Additional Manufacturer Narrative
(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.