PIPELINE 288205041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034220413), received between Jan 18, 2023 and Jan 18, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON BROKE THE PITUITARY WHILE DECOMPRESSING. IT WAS UNKNOWN WHETHER THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME / CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 6MM PITUITARY W/TEETH. THIS IS REPORT 2 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196101 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON BROKE THE PITUITARY WHILE DECOMPRESSING. IT WAS UNKNOWN WHETHER THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME / CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 6MM PITUITARY W/TEETH. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196010 ↗