Integra® Jarit® 400143Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780391500), received between Jan 13, 2023 and Jan 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE NEW COTTLE NASAL SPEC SZ 4 55MM (400143) "WERE ABOUT TO BE PUT IN THE INSTRUMENT TRAYS WHEN THE DAMAGED INSTRUMENTS WERE NOTICED". THE USER REPORTEDLY "RECEIVED METAL SPLINTERS IMBEDDED IN THE THUMB AND FINGERS, REQUIRING FORCEPS TO REMOVE THE METAL SPLINTERS". "PRODUCT HAS IMPERFECTIONS REGARDING THE INSTRUMENT FINISH, AND METAL SPLINTERS ARE BEING SHED, RESULTING IN PHYSICAL INJURY OF THE USER." THE USER WAS NOT PERMANENTLY INJURED AND DID NOT HAVE TO SEEK MEDICAL ASSISTANCE FOR INJURY. IT WAS REPORTED THAT THE DEVICE WAS NOT USED IN PROCEDURE, THUS NO PATIENT IMPACT AND NO DELAY IN PROCEDURE OCCURRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16162950 ↗