Ultrasound Probe M0068407170Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729516613), received between Apr 12, 2018 and Apr 1, 2021 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2021Break; Overheating of Device; Electrical Power Problem; Break; Overheating of Device; Electrical Power Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01244 FOR THE LITHOCLAST ULTRASOUND PROBE, MFR REPORT #3005099803-2021-01245 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01247 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602327 ↗
• MalfunctionApr 1, 2021Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE HANDPIECE WAS HOT AS WELL AS THE AT THE PROBE CONNECTION SITE. THE ULTRASOUND PROBE BROKE, 350 MILLIMETERS DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A NEW LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 1, 2021: DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBE BROKE AT THE PROXIMAL END NEAR THE JUNCTION WITH THE HANDPIECE (AND NEAR THE PROXIMAL END OF THE NEPHOSCOPE). THE PIECE THAT BROKE OFF OF THE PROBE WAS APPROXIMATELY 35 CM LONG. IT WAS REPORTED THAT THERE WAS STILL PLENTY OF LENGTH OUTSIDE THE PATIENT FOR THE PHYSICIAN TO GRAB AND REMOVE THE ENTIRE LENGTH OF THE BROKEN PIECE. A NEW LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602015 ↗
• MalfunctionApr 1, 2021Break; Overheating of Device; Electrical Power Problem; Break; Overheating of Device; Electrical Power Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. THE LITHOCLAST ULTRASOUND PROBE, MFR REPORT #3005099803-2021-01245 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01247 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602012 ↗
• MalfunctionApr 1, 2021Break; Overheating of Device; Electrical Power Problem; Break; Overheating of Device; Electrical Power Problem

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01244 FOR THE LITHOCLAST ULTRASOUND PROBE, MFR REPORT #3005099803-2021-01245 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE THREE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE AND THE HANDPIECE WAS HOT. THE PROBES WORKED EFFECTIVELY AT THE BEGINNING AND AS THEY WERE CONTINUALLY USED THEY BECAME WEAKER AND EVENTUALLY BROKE. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. BY THE THIRD PROBE, THE PHYSICIAN NOTICED THE BREAK PRIOR TO THE FULL SEPARATION OF THE PROBE FROM THE HANDPIECE. THE PROCEDURE WAS COMPLETED WITH A FOURTH LITHOCLAST ULTRASOUND PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602011 ↗
• MalfunctionApr 1, 2021Break; Overheating of Device; Break; Overheating of Device

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT #3005099803-2021-01231 FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE. THE PHYSICIAN NOTED THAT THE HANDPIECE WAS HOT AND THE HANDPIECE WAS TRANSFERRING HEAT TO THE PROBE AT THE CONNECTION SITE, POTENTIALLY MAKING THE PROBES WEAKER AND CONTRIBUTING TO THEIR BREAK. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A THIRD LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601683 ↗
• MalfunctionApr 1, 2021Break; Overheating of Device; Break; Overheating of Device

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2021-01230 FOR THE LITHOCLAST ULTRASOUND PROBE AND MFR REPORT FOR THE LITHOCLAST ULTRASOUND PROBE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO LITHOCLAST ULTRASOUND PROBES WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE ULTRASOUND PROBES BROKE NEAR THE CONNECTION SITE. THE PHYSICIAN NOTED THAT THE HANDPIECE WAS HOT AND THE HANDPIECE WAS TRANSFERRING HEAT TO THE PROBE AT THE CONNECTION SITE, POTENTIALLY MAKING THE PROBES WEAKER AND CONTRIBUTING TO THEIR BREAK. IT WAS REPORTED 350 MILLIMETERS OF THE PROBE DETACHED INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED USING REUSABLE GRASPERS. A THIRD LITHOCLAST PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601682 ↗
• MalfunctionOct 9, 2020Break; Material Deformation; Appropriate Device Problem Term/Code Not Available; Break; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE AND WAS UNABLE TO REMOVE THE BROKEN PROBE FROM THE HANDPIECE. NOTHING DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WAS NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658555 ↗
• InjuryApr 24, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE BROKE IN HALF MIDWAY THROUGH THE PROCEDURE AND THE BROKEN PIECE WAS REMOVED FROM THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCLAST ULTRASOUND PROBE. THERE WERE NO SERIOUS INJURY/ADVERSE EFFECT TO PATIENT AS A RESULT OF THE EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545266 ↗
• MalfunctionFeb 5, 2019Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A LITHOCLAST ULTRASOUND PROBE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ULTRASOUND PROBE WAS USED AND IT OVERHEATED AND BROKE IN HALF. REPORTEDLY, THERE WERE NO BROKEN FRAGMENTS THAT FELL INSIDE THE PATIENT AND THE PATIENT WAS NOT BURNED DUE TO OVERHEATING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LITHOCLAST ULTRASOUND PROBE. THERE WAS NO SERIOUS INJURY OR ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306005 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A LITHOCLAST 3.8MM X 403MM ULTRASOUND DISPOSABLE PROBE WAS USED IN A PROCEDURE PERFORMED ON (B)(6)2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ULTRASOUND PROBE GOT BUSTED. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS, WHICH REVEALED THAT THE ULTRASOUND PROBE WAS BROKEN AND BECAUSE OF THE AMBIGUITY OF WHERE THE FRAGMENTS DETACHED. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8130471 ↗
• MalfunctionJul 31, 2018Break

  THE ULTRASOUND PROBE BUSTED. IT WAS REMOVED FROM THE FIELD AND A NEW ONE WAS OBTAINED.

  Patient problems: No Information

  MAUDE report 7734911 ↗
• MalfunctionApr 20, 2018Device Packaging Compromised; Device Packaging Compromised

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES SUPPOSED TO BE USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01256 AND 3005099803-2018-01257 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 04, 2018 THAT THREE LITHOCLAST ULTRASOUND PROBES WERE OPENED TO BE USED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE PACKAGING INCLUDING THE STERILE POUCH WAS NOTED TO BE CRUMPLED ON ALL THREE LITHOCLAST ULTRASOUND PROBES. THE PLASTIC PACKAGING WAS ALSO BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCLAST ULTRASOUND PROBE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447297 ↗
• MalfunctionApr 20, 2018Device Packaging Compromised; Device Packaging Compromised

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES SUPPOSED TO BE USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01255 AND 3005099803-2018-01256 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 04, 2018 THAT THREE LITHOCLAST ULTRASOUND PROBES WERE OPENED TO BE USED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE PACKAGING INCLUDING THE STERILE POUCH WAS NOTED TO BE CRUMPLED ON ALL THREE LITHOCLAST ULTRASOUND PROBES. THE PLASTIC PACKAGING WAS ALSO BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCLAST ULTRASOUND PROBE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447286 ↗
• MalfunctionApr 20, 2018Device Packaging Compromised; Device Packaging Compromised

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES SUPPOSED TO BE USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01255 AND 3005099803-2018-01257 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT THREE LITHOCLAST ULTRASOUND PROBES WERE OPENED TO BE USED FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, THE PACKAGING INCLUDING THE STERILE POUCH WAS NOTED TO BE CRUMPLED ON ALL THREE LITHOCLAST ULTRASOUND PROBES. THE PLASTIC PACKAGING WAS ALSO BENT UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER LITHOCLAST ULTRASOUND PROBE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447267 ↗
• InjuryApr 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION AN ULTRASOUND PROBE WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE ULTRASOUND PROBE BROKE IN HALF, INSIDE THE PATIENT, AT THE CLOSE OF THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED USING A PAIR OF GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426137 ↗