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Thoracoport 179308Recalls & reported problems

Covidien LP · Soft Trocar · Class 2

All models of Thoracoport (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521081212), received between Mar 12, 2018 and Jul 30, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (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

Device problems

  • Packaging Problem3
  • Break2
  • Product Quality Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Tissue Damage1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 30, 2021Break; Product Quality Problem; Break; Product Quality Problem

    ACCORDING TO THE REPORTER, DURING THE INITIAL INSERTION ON A LAPAROSCOPIC PULMONARY RESECTION, THE TIP OF THE DEVICE HAD BEEN MISSING FROM THE TIME IT WAS OPENED FROM THE PACKAGE. IT WAS STATED THAT THE CANNULA BROKE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12255117 ↗
  • MalfunctionJan 22, 2021Packaging Problem; Packaging Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON NOTED THAT THE TIP OF THE OUTER CYLINDER HAD BEEN BROKEN. THERE WAS NO PARTICULAR ABNORMALITY ON FORCEPS OPERATION OR THE LIKE. AS SOON AS IT WAS NOTED, A NEW ONE WAS USED TO RESOLVE THE PROBLEM. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11214722 ↗
  • MalfunctionDec 2, 2019Packaging Problem; Packaging Problem

    ACCORDING TO THE REPORTER, DURING A THORACO LOBECTOMY, THE TIP PART OF THE GRAY CANNULA HAD AGNAIL. THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9399394 ↗
  • InjurySep 3, 2019Packaging Problem; Packaging Problem

    ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE OPERATION OF A THORACO LOBECTOMY, WHEN INSERTING THE TROCAR AS THE 2ND PORT, A CRACK WAS FOUND AT THE TIP OF THE TROCAR WHEN OBSERVING WITH A CAMERA. IT WAS STATED THAT THERE WAS A SCRATCH LIKE AN AGNAIL. WHEN THE TROCAR WAS REMOVED TO BE REPLACED BY A NEW ONE, THE TISSUE WAS DAMAGED AS THE AGNAIL ON THE TROCAR RUBBED INTO THE TISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

    Patient problems: Tissue Damage

    MAUDE report 8954529 ↗
  • MalfunctionMar 12, 2018Break; Break

    ACCORDING TO THE REPORTER, DURING WEDGE SEGMENTAL RESECTION, AFTER INSERTING THE DEVICE INTO THE CAVITY, SURGEON FOUND THROUGH A SCOPE THAT THE TIP OF THE DEVICE WAS DEFORMED. THERE WAS NO INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7332588 ↗

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Sources and updates

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