SYMMETRY SURGICAL DISPOSABLE VEIN STRIPPER
Received Aug 8, 2014 · Event occurred Jul 18, 2014
Report 3007208013-2014-00014 · MDR key 4017324
Device
Product problems
- Difficult to Remove
Patient
Not reported
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
DEVICE CANNOT BE STERILIZED AND THUS WILL NOT BE RETURNED.
Description of Event or Problem
THE SYMMETRY SURGICAL DISPOSABLE VEIN STRIPPER CONSISTS OF A TWO END CABLE, OLIVE, AND HANDLE FOR USE IN THE REMOVAL OF SAPHENOUS VARICOSE VEINS. THE CABLE IS INSERTED INTO EITHER END OF THE VEIN. THE OLIVE AND HANDLE ARE SNAPPED INTO POSITION ON THE ENDS OF THE CABLE AFTER IT HAS BEEN INSERTED IN THE VEIN. NARRATIVE FROM INITIAL REPORTER. "PROCEDURE WAS PROCEEDING AS NORMAL UNTIL THE REGISTRAR STARTED TO PULL THE STRIPPER BACK UP THROUGH THE VEIN. WHEN THE STRIPPER REACHED THE KNEE SOME RESISTANCE WAS ENCOUNTERED. EXTRA PRESSURE WAS APPLIED AND THE LINE CAME THROUGH THE OLIVE. THE OLIVE WAS NOT FOUND BY USING ULTRASOUND. MRI WAS SCHEDULED FOR (B)(6) 2014. OLIVE WAS LOCATED UNDER MRI IN THE PATIENT'S THIGH. THE ISSUE HAS NOT CAUSED ANY OTHER ISSUES OR DISCOMFORT. SURGERY HS BEEN SCHEDULED TO REMOVE THE OLIVE."