Portex 66-1991Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10788942619913), received between Sep 4, 2018 and Mar 3, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE IT WAS SO CHALLENGING FOR THE DOCTOR TO REMOVE THE SCOPE FROM THE SWIVEL CONNECTOR, THE DEVICE SHEARED. CONCOMITANT MEDICAL PRODUCTS/THERAPIES REPORTED WERE: BF-1TH190 AND BF-UC180F. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16481492 ↗
• MalfunctionMar 2, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE IT WAS SO CHALLENGING FOR THE DOCTOR TO REMOVE THE SCOPE FROM THE SWIVEL CONNECTOR, THE DEVICE SHEARED. CONCOMITANT MEDICAL PRODUCTS/THERAPIES REPORTED WERE: (B)(4). THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16472896 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING USE BY THE SURGEON, THE SWIVEL ADAPTOR MALFUNCTIONED. IT WAS REPLACED WITH A SECOND IDENTICAL SWIVEL ADAPTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414953 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING USE BY THE SURGEON, THE SWIVEL ADAPTOR MALFUNCTIONED. IT WAS REPLACED WITH A SECOND IDENTICAL SWIVEL ADAPTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414333 ↗
• MalfunctionApr 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE ITEM IN QUESTION HAS SLITS IN THEM SO THEY LEAK ISOFLURANE AND ARE QUESTIONING IF THE SLITS ARE SUPPOSED TO BE ON THIS ITEM AT THE RUBBER STOPPER. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043147 ↗
• MalfunctionNov 6, 2020Defective Device

  SURGEON USED A SWIVEL ADAPTOR. DEVICE MALFUNCTIONED, WAS REPLACED WITH A SECOND IDENTICAL SWIVEL ADAPTOR. SECOND DEVICE ALSO MALFUNCTIONED.

  Patient problems: Insufficient Information

  MAUDE report 10800971 ↗
• InjuryMay 9, 2019Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  IT WAS REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE, THE BLUE TOP OF THE ELBOW SEPARATED FROM THE ELBOW. WHEN THE SEPARATION OCCURRED IT CAUSED THE ET TUBE TO BE PULLED OUT OF THE PATIENT. AN URGENT RE-INTUBATION OF A NEW ET TUBE WAS PERFORMED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER THIS INTERVENTION WAS TAKEN. IT WAS FURTHER REPORTED THAT AFTER FURTHER DISCUSSIONS WITH THE RESPIRATORY TECHS, THE REPORTER BELIEVED THAT THE ISSUES COULD HAVE BEEN ATTRIBUTED TO USER ERROR. THE REPORTER STATED THAT A THERAPEUTIC BRONCHOSCOPY SCOPE WAS USED IN A SMALL TRACH, AND WHEN IT BECAME LODGED IN THE TRACH, EVERYTHING CAME APART".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597252 ↗
• MalfunctionSep 4, 2018Stretched; Stretched

  INFORMATION WAS RECEIVED INDICATING THAT THE BRONCHOSCOPE WAS UNABLE TO BE PASSED THROUGH A SMITHS MEDICAL SWIVEL CONNECTOR AEROSOL ADAPTER CAUSING THE SCOPE SHEATH TO STRETCH. IT WAS NOTED THAT THE SCOPE WAS THEN NEEDING TO BE REPAIRED. THE SEAL WAS REPORTED TO BE TOO TIGHT AND THAT THE PROCEDURE WAS UNABLE TO BE PERFORMED ON THE CRITICAL PATIENT. THERE WERE REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844336 ↗