NA 242143Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705032044), received between Jan 27, 2023 and May 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Deformation

  IT WAS REPORTED THAT THE BUTTON OBTURATOR 4.0 DEVICE WAS BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092837 ↗
• MalfunctionApr 17, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BUTTON OBTURATOR COMPATIBLE WITH 4.0MM ENDOSCOPIC SYSTEM SCOPE TROCAR WAS FOUND BENT. THERE WAS NO PATIENT INVOLVED WITH THE EVENT. NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION NOTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910124 ↗
• MalfunctionApr 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE IT WAS OBSERVED THAT THE OBT_BUTTON_4.0,167_MITEK DEVICE TROCAR WAS BENT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933754 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BUTTON OBTURATOR COMPATIBLE WITH 4.0MM ENDOSCOPIC SYSTEM, MITEK LOCK DEVICE WAS BENT AND WOULD NOT FIT DOWN THE SHEATH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685717 ↗
• MalfunctionJan 27, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BUTTON OBTURATOR COMPATIBLE WITH 4.0MM ENDOSCOPIC SYSTEM, MITEK LOCK DEVICE WAS DAMAGED AND BENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED MINOR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255986 ↗