NA 214119Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003600), received between Jun 14, 2023 and Sep 19, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Crack; Crack

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING STERILE PROCESSING, IT WAS OBSERVED THAT THE RUBBER ON THE 7.0 X 75MM REUSABLE OBTURATOR -NS DEVICE AND 8.5 X 75MM REUSABLE OBTURATOR -NS DEVICE WAS PEELING AND EXHIBITED SPLITS. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256409 ↗
• MalfunctionJun 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 8.5 X 75MM REUSABLE OBTURATOR -NS DEVICE, WHEN POSITIONING THE CANNULA AND PLACING THE OBTURATOR OVER THE SWITCHING STICK IT WAS DISCOVERED THAT THE CANNULA WAS BENT. IT IS UNKNOWN WHETHER ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE OR WHETHER THERE WERE ANY DELAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484391 ↗
• MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE REUSABLE OBTURATOR 8.5 X 75MM DEVICE WAS CONTAMINATED UPON INSPECTION. 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 17128488 ↗