VSP 202549Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034000398), received between Jan 8, 2019 and Dec 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BALL TIP FEELERS BROKE. THE FEELERS WERE BENT AND WHEN THE SCRUB TRIED STRAIGHTENING THEM OUT THE TIPS CAME OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832308 ↗
• MalfunctionDec 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BALL TIP FEELERS BROKE. THE FEELERS WERE BENT AND WHEN THE SCRUB TRIED STRAIGHTENING THEM OUT THE TIPS CAME OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832276 ↗
• MalfunctionDec 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE BALL TIP FEELERS BROKE. THE FEELERS WERE BENT AND WHEN THE SCRUB TRIED STRAIGHTENING THEM OUT THE TIPS CAME OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832273 ↗
• MalfunctionJul 17, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE INNER SHAFT BROKE ON INSERTER. BALL TIP PROBES BENT. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE UNKNOWN PROBE THIS IS REPORT 2 OF 2 FOR (B)(4). (B)(4) IS RELATED TO (B)(4) . (B)(4) IS CAPTURE THE EVENT, INNER SHAFT BROKE ON INSERTER. (SPN OPCO). (B)(4) IS CREATED TO CAPTURE THE EVENT, BALL TIP PROBES BENT. (SPD OPCO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765124 ↗
• MalfunctionJul 17, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE INNER SHAFT BROKE ON INSERTER. BALL TIP PROBES BENT. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE UNKNOWN PROBE THIS IS REPORT 1 OF 2 FOR (B)(4). (B)(4) IS RELATED TO (B)(4). (B)(4) IS CAPTURE THE EVENT, INNER SHAFT BROKE ON INSERTER. (SPN OPCO). (B)(4) IS CREATED TO CAPTURE THE EVENT, BALL TIP PROBES BENT. (SPD OPCO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765025 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED THAT THE SURGEON REPORTED BALL TIP BROKE OFF END OF PROBE DURING NORMAL USE. ANOTHER PROBE WAS OPENED, TIP WAS RETRIEVED AND NO UNACCOUNTED FRAGMENTS. CUSTOMER REFERENCE/PO/SERVICE: (B)(4). WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? OPENED A SECOND PACKAGE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327869 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED THE MOUNTAINEER BALL TIP PROBE WAS FOUND WITH TIP BROKEN OFF IN MDRD. CAUSE WAS NOT KNOWN AND THE INSTRUMENT WAS INADVERTENTLY THROWN AWAY. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227795 ↗