Ultrasound Probe M0068407160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729516606), received between Dec 27, 2017 and Jan 16, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRASOUND PROBE WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE ABOUT 4CM FROM THE PROXIMAL END. HALF OF THE BROKEN PIECE FELL INSIDE THE PATIENT AND WAS RETRIEVED WITH THE USE OF FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7193258 ↗
• InjuryDec 27, 2017Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT 3005099803-2017-03909 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TEN MINUTES INTO THE PROCEDURE, THE FIRST ULTRASOUND PROBE (THE SUBJECT OF THIS MFR REPORT) BROKE IN HALF WHEN THE LITHOCLAST WAS AT LEVEL 90. THE SAME ISSUE HAPPENED WITH THE SECOND ULTRASOUND PROBE (MFR REPORT #3005099803-2017-03909). THE BROKEN PIECES WERE RETRIEVED FROM INSIDE THE PATIENT WITH THE USE OF A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE AND ALSO A HOLMIUM LASER. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148066 ↗
• InjuryDec 27, 2017Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT 3005099803-2017-03908 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TEN MINUTES INTO THE PROCEDURE, THE FIRST ULTRASOUND PROBE (MFR REPORT # 3005099803-2017-03908) BROKE IN HALF WHEN THE LITHOCLAST WAS AT LEVEL 90. THE SAME ISSUE HAPPENED WITH THE SECOND ULTRASOUND PROBE (THE SUBJECT OF THIS MFR REPORT). THE BROKEN PIECES WERE RETRIEVED FROM INSIDE THE PATIENT WITH THE USE OF A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE AND ALSO A HOLMIUM LASER. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148058 ↗