MUELLER PHLEB HK RGHT SZ2 5 IN PHLEBECTOMY HOOK
Received Jun 15, 2017 · Event occurred Apr 7, 2017
Report 9611112-2017-00002 · MDR key 6642645
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED WITHOUT THE BROKEN-OFF TIP. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. SINCE THE DEVICE WAS RETURNED INCOMPLETE, I.E., WITHOUT THE BROKEN-OFF TIP, IT IS NOT POSSIBLE TO REACH A DEFINITE CONCLUSION WITH REGARD TO THE CAUSE OF THE FRACTURE. HOWEVER, THIS TYPE OF HOOK HAS A VERY DELICATE TIP RANGING FROM 0.5MM TO 1.0MM IN WIDTH DUE TO THE NATURAL ANATOMICAL REQUIREMENTS OF THE VEIN-STRIPPING PROCEDURE, AND THE TIP MAY FRACTURE IF EXCESSIVE PRESSURE IS APPLIED BY THE SURGEON. THUS THE DEVICE MOST LIKELY WAS NOT USED IN ACCORDANCE WITH RECOGNIZED BEST PRACTICES. A REVIEW OF COMPLAINT HISTORY FOR THIS DEVICE FOR THE LAST THREE YEARS REVEALED NO SIMILAR CASES.
Description of Event or Problem
CUSTOMER REPORTS DEVICE TIP BROKE OFF DURING A VEIN LIGATION AND STRIPPING ON LEFT LEG. TIP RETRIEVED, NO PATIENT HARM. DEVICE #1 OF 3 USED DURING SAME PROCEDURE.