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E-PACK 9480ERecalls & reported problems

Ethicon Inc. · E-Pack Procedure Kit · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705031235233), received between Jul 22, 2020 and Sep 8, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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

Device problems

  • Use of Device Problem6

Patient problems

  • Extubate3
  • No Clinical Signs, Symptoms or Conditions2
  • Unintended Extubation1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 8, 2023Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE COULD NOT BE MECHANICALLY VENTILATED AS THE CUFF WAS FOUND "RUPTURED" DURING THE PR OCEDURE. THE MEDICAL STAFF IMMEDIATELY REPLACED IT WITH A NEW TUBE.

    Patient problems: Unintended Extubation

    MAUDE report 17715932 ↗
  • MalfunctionSep 1, 2023Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF WAS IMPOSSIBLE TO DEFLATE COMPLETELY DURING SCHEDULED EXTUBATION. ASPIRATION WAS NEEDED BEFORE THE EXTUBATION. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17673713 ↗
  • MalfunctionSep 14, 2021Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12470112 ↗
  • MalfunctionJul 22, 2020Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CUFF DEFLATED AND THERE WAS A LOSS OF MECHANICAL BREATHING DUE TO DEFECTED CUFF. IT HAPPENED THREE TIMES WITH THE SAME PATIENT. IT WAS INDICATED THAT THEY CHANGED THE TUBE THREE TIMES.

    Patient problems: Extubate

    MAUDE report 10311188 ↗
  • MalfunctionJul 22, 2020Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CUFF DEFLATED AND THERE WAS A LOSS OF MECHANICAL BREATHING DUE TO DEFECTED CUFF. IT HAPPENED THREE TIMES WITH THE SAME PATIENT. IT WAS INDICATED THAT THEY CHANGED THE TUBE THREE TIMES.

    Patient problems: Extubate

    MAUDE report 10311013 ↗
  • MalfunctionJul 22, 2020Use of Device Problem; Use of Device Problem

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CUFF DEFLATED AND THERE WAS A LOSS OF MECHANICAL BREATHING DUE TO DEFECTED CUFF. IT HAPPENED THREE TIMES WITH THE SAME PATIENT. IT WAS INDICATED THAT THEY CHANGED THE TUBE THREE TIMES.

    Patient problems: Extubate

    MAUDE report 10310882 ↗

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.