NA 288205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026838), received between Jun 10, 2022 and Aug 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING LOAN KIT INSPECTION, IT WAS OBSERVED THAT THE METAL BLADE ON THE SUBSCAPULARIS CHANNELER DEVICE SNAPPED OFF FROM ITS HANDLE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140232 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUBSCAPULARIS CHANNELER DEVICE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658851 ↗