DEK BL MF 0 TC-43/HR 26 2N 36"
Received Aug 25, 2015 · Event occurred Jul 22, 2015
Report 3004365956-2015-00223 · MDR key 5029239
Device
Product problems
- Break
Patient
Not reported
- 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 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.
Description of Event or Problem
ALLEGED EVENT: THE HARPOON BROKE AND WAS LEFT INSIDE THE PATIENT. TO INSERT THE SUTURE, A CAPIO WAS USED. A NEW CAPIO AND A NEW SUTURE WAS USED. AT THE SECOND ATTEMPT THE HARPOON NEEDLE PROBABLY GOT STUCK IN CAPIO. THE HARPOON NEEDLE WAS NOT FOUND AND A THREAD STUCK OUT OF THE CAPIO. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.