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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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