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Thoracoport 179309Recalls & reported problems

Covidien LP · Soft Trocar · Class 2

All models of Thoracoport (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884521081229), received between Feb 9, 2018 and Dec 3, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break3
  • Material Split, Cut or Torn3
  • Detachment Of Device Component1
  • Detachment of Device or Device Component1
  • Device Contamination with Chemical or Other Material1
  • Difficult to Insert1
  • Difficult to Remove1
  • Environmental Particulates1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • No Consequences Or Impact To Patient2
  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • MalfunctionDec 3, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

    ACCORDING TO THE REPORTER DURING A THORACOSCOPY PROCEDURE, THE LOWER PART OF THE SLEEVE HAD TORN OFF. NO COMPONENT FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23702940 ↗
  • MalfunctionSep 10, 2025Break; Difficult to Insert; Break; Difficult to Insert

    ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL RESECTION OF THE RIGHT UPPER LOBE, AT THE TIME OF PORT PLACEMENT, WHEN IT WAS REMOVED AND INSERTED, THERE WAS CATCH (DIFFICULT TO INSERT). IT WAS ALSO NOTED THAT THE CANNULA BROKE. A NEW PORT WAS PROVIDED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23015137 ↗
  • MalfunctionFeb 6, 2024Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL PULMONARY RESECTION, WHEN PREPARING THE DEVICE, THERE WAS A GREEN FOREIGN OBJECT ON THE INSIDE. IT WAS ALSO REPORTED THAT THE TROCAR RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18655972 ↗
  • MalfunctionFeb 17, 2023Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

    ACCORDING TO THE REPORTER, BEFORE THE START OF THE SURGERY, THE SEALS FROM THE SEVEN DEVICES WERE DAMAGED. IT WAS NOTED THAT THE TIP OF THE PORT WAS SLIMY, MOISTURE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16396242 ↗
  • MalfunctionFeb 15, 2022Environmental Particulates; Material Split, Cut or Torn; Environmental Particulates; Material Split, Cut or Torn

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY WHILE IN THE STOCK, BEFORE OPENING THE TWELVE MILLIMETER DEVICE, A BLACK FOREIGN MATERIAL WAS ATTACHED TO THE OBTURATOR. THERE IS ALSO A SEAL DAMAGED. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13534067 ↗
  • MalfunctionOct 14, 2019Difficult to Remove; Difficult to Remove

    ACCORDING TO THE REPORTER, DURING A LUNG RESECTION, AFTER THE THIRD FIRING, WHEN ATTEMPTING TO REMOVE THE RELOAD OUT OF THE THORACIC CAVITY THROUGH A PORT, THE REMOVAL FAILED. WHEN CHECKING WITH THE CAMERA, THE JAWS PART OF THE RELOAD WAS FOUND TO BE BROKEN. THE CARTRIDGE WAS REMOVED ALONG WITH THE TROCAR TOGETHER AND THE ISSUE WAS SOLVED. AFTER REMOVAL, THE STAPLE LINE WAS CHECKED AND NO PROBLEM WAS FOUND. ANOTHER RELOAD, WHICH WAS TAKEN OUT FOR THE NEXT FIRING, WAS CONSIDERED TO BE UNABLE TO BE FIRED WITH THE REPORTED HANDLE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9189106 ↗
  • MalfunctionMar 27, 2019Packaging Problem; Packaging Problem

    ACCORDING TO THE REPORTER, WHEN INSERTING THE DEVICE DURING A VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE TROCAR HIT THE ANVIL SEVERAL TIMES AND SEEMED TO BE BROKEN. UPON REMOVAL OF THE TROCAR, BREAKAGE WAS FOUND. IT WAS STATED THAT NOTHING FELL INTO THE PATIENT'S CAVITY. THE TROCAR WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8455829 ↗
  • InjuryFeb 9, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

    ACCORDING TO THE REPORTER, DURING THE RIGHT LOWER THORACO/LOBECTOMY PROCEDURE, THE DEVICE WAS USING WITHOUT PROBLEM, BUT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE CANNULA WAS NOTED TO BE CHIPPED. SURGEON SEARCHED BROKEN PIECES IN THE PATIENT BODY WITH ENDOSCOPE, BUT NOTHING WAS FOUND. SINCE THE EVENT WAS OCCURRED AFTER THE PROCEDURE, THE OPERATION WAS COMPLETED. THE STATUS OF THE PATIENT: NO PROBLEM.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7261437 ↗

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Sources and updates

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