VARADY PHLEBECTOMY EXTRACTOR, 6-3/4 SM HOOK
Received Jun 10, 2018 · Event occurred Apr 11, 2018
Report 9611112-2018-00003 · MDR key 7585423
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. IT HAD BEEN MANUFACTURED IN NOVEMBER 2017. REVIEW OF MANUFACTURING RECORDS CONFIRMED DEVICE CONFORMANCE TO SPECS AT TIME OF RELEASE. HARDNESS OF RETURNED DEVICE WAS TESTED AND FOUND CONFORMING TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO MICROSCOPIC EXAMINATION. IT SHOWED NO EVIDENCE OF EXTENSIVE REUSE. 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 EXTRACTOR HAS A VERY DELICATE HOOK TIP AND THE TIP MAY FRACTURE IF EXCESSIVE PRESSURE IS APPLIED BY THE SURGEON.
Description of Event or Problem
DURING AN UNSPECIFIED PROCEDURE THE HOOK OF THE VARADY PHLEBECTOMY EXTRACTOR BROKE OFF. NO PATIENT CONTACT, INJURY, OR SURGERY DELAY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NO OTHER CLINICAL INFORMATION HAS BEEN PROVIDED.