n/a 8000-050-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327413205), received between Sep 18, 2020 and Sep 14, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that the pointer tip broke during a medical procedure. The procedure was completed successfully with a replacement product. No adverse consequences were reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750065 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component

  It was reported that the Precision Pointer broke into half at first use when trying to perform the patient registration. No adverse consequences were reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750063 ↗
• MalfunctionSep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707581 ↗
• MalfunctionSep 9, 2026Incorrect Measurement

  It was reported that a new Precision Pointer (first use) was inaccurate during patient registration, displaying a position approximately one inch off bone when touching the patient's lateral canthi. The pointer was replaced and the issue was resolved. A surgical delay of 10 minutes was reported. No adverse consequences or any medical intervention were reported at intake.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683603 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560840 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  It was reported that the device broke while being inserted into the nasal cavity. The issue occurred intraoperatively and led to surgical delay. No adverse consequences, or additional medical intervention were reported at intake.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299924 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299587 ↗
• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298033 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  During the first use of the pointer, the surgeon placed the pointer inside the patient and identified the frontal sinus. As the pointer was being removed, it came apart at pointer tube. The device was then removed from the field and the procedure was completed successfully with another pointer, without a clinically significant delay; no adverse consequences or medical intervention were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221908 ↗
• InjuryAug 12, 2026Detachment of Device or Device Component

  It was reported that during use, the pointer was inserted into the nose. Upon removal, the extended tip detached and remained in the surgical field, requiring separate retrieval.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218512 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  It was reported that during the third use, the device broke in half while attempting to perform patient registration. No adverse consequences, surgical delay or any medical intervention were reported at intake.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218511 ↗
• MalfunctionSep 18, 2020No Device Output; Deformation Due to Compressive Stress; No Device Output; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE PHYSICIAN USED THE PRECISION POINTER, BUT BENT IT ABOVE THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10554166 ↗