ULTRATOME¿ RX
Report
- Report Number
- 3005099803-2013-00777
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 20, 2013
- Report Date
- January 21, 2013
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- KNS
- PMA / PMN Number
- K970053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH OF THE DEVICE WAS TWISTED AND PAINT HAD PEELED OFF THE DISTAL TIP. THE CUTTING WIRE LENGTH WAS MEASURED AND FOUND TO MEET SPECIFICATION. FUNCTIONAL EVALUATION FOUND THAT THE ELECTRICAL RESISTIVITY OF THE DEVICE MET SPECIFICATION AND THE DEVICE BOWED ACCORDING TO SPECIFICATION. THE DEVICE FUNCTIONED AS INTENDED WITH RESPECT TO ELECTRICAL FUNCTIONALITY. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. RESULTS: ALTHOUGH THE FULL INVESTIGATION DID NOT CONFIRM THAT THE DEVICE WOULD NOT CUT, THE OPERATIONAL PROBLEM IS BEING USED TO CAPTURE THE TWISTED WORKING LENGTH AND PEELED PAINT.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. (MFR. REPORT #3005099803-2013-00776 AND MFR. REPORT #3005099803-2013-00777). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRATOME RX DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN SPHINCTEROTOMY WAS ATTEMPTED WITH THE FIRST ULTRATOME (MFR. REPORT #3005099803-2013-00776), THE DEVICE WOULD NOT CUT. THE DEVICE WAS REMOVED FROM THE PATIENT. THE SECOND ULTRATOME DEVICE (SUBJECT OF THIS REPORT) WAS INTRODUCED INTO THE PATIENT, BUT THIS DEVICE WOULD NOT CUT EITHER. THE DEVICES WERE TESTED WITH TWO DIFFERENT BSC ACTIVE CORDS, BUT THE ISSUE REMAINED. FINALLY, THE ENDOSTAT GENERATOR WAS TURNED UP TO "50", AND SOME BLANCHING OF THE TISSUE WAS OBSERVED INDICATING CAUTERY. THE PROCEDURE WAS COMPLETED WITH THIS SECOND ULTRATOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. (MFR. REPORT #3005099803-2013-00776 AND MFR. REPORT #3005099803-2013-00777). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRATOME RX DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN SPHINCTEROTOMY WAS ATTEMPTED WITH THE FIRST ULTRATOME (MFR. REPORT #3005099803-2013-00776), THE DEVICE WOULD NOT CUT. THE DEVICE WAS REMOVED FROM THE PATIENT. THE SECOND ULTRATOME DEVICE (SUBJECT OF THIS REPORT) WAS INTRODUCED INTO THE PATIENT, BUT THIS DEVICE WOULD NOT CUT EITHER. THE DEVICES WERE TESTED WITH TWO DIFFERENT BSC ACTIVE CORDS, BUT THE ISSUE REMAINED. FINALLY, THE ENDOSTAT GENERATOR WAS TURNED UP TO "50", AND SOME BLANCHING OF THE TISSUE WAS OBSERVED INDICATING CAUTERY. THE PROCEDURE WAS COMPLETED WITH THIS SECOND ULTRATOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59189 | ULTRATOME¿ RX | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M00545050 | 15560900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | BSC ENDOSTAT GENERATOR| BSC ACTIVE CORD (TWO USED) |