GRYPHON 211038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705001507), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE OBTURATOR FOR STORZ/LINVATEC SHEATH (281332) DEVICE WAS BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17209805 ↗