MalfunctionMFJ
DEK BL MF 0 TC-43/HR 26 2N 36"
Received Apr 25, 2016 · Event occurred Apr 8, 2016
Report 3004365956-2016-00201 · MDR key 5604518
Device
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
QN#(B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: DURING PLACEMENT OF THE CAPIO SUTURE WHILE PERFORMING THE BITE, THE BULLET TIP JAMMED IN THE HEAD OF THE CAPIO SLIM DEVICE AND THE SUTURE BROKE. THEY USED A SECOND CAPIO SLIM AND A NEW SUTURE TO FINISH THE PROCEDURE WITHOUT ANY PROBLEMS. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.