Thoracoport 179301Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521081175), received between Apr 17, 2017 and Dec 8, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE, ONCE THE INCISION WAS ALMOST CLOSED, IT WAS NOTICED THAT THE TROCAR WAS NOT INTACT. A FRAGMENT HAD BROKEN OFF AND FALLEN INTO THE CHEST OF THE PATIENT. IT WAS THEREFORE NECESSARY TO REOPEN THE PATIENT TO RETRIEVE THE FRAGMENT. EXTENSION OF SURGERY WAS DONE IN ORDER TO RETRIEVE THE LOST FRAGMENT INSIDE THE THORAX.

  Patient problems: Tissue Breakdown

  MAUDE report 23752720 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BYPASS PROCEDURE, THE TROCAR BROKE WHILE BEING INTRODUCED INTO THE PATIENT¿S THORAX, RESULTING IN PLASTIC DEBRIS SHATTERING INSIDE THE THORAX. THE PLASTIC DEBRIS FELL INTO THE PATIENT¿S THORAX AND REQUIRED RETRIEVAL BY THE SURGEON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595343 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, PART OF THE PRODUCT WAS MISSING WHEN IT WAS OPENED. THE CANNULA BROKE AND DISENGAGED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734386 ↗
• MalfunctionFeb 13, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A OPEN THORACIC SURGERY, THE END OF THE TROCAR SHEATH BROKE IN THE PATIENT'S CHEST. THE MISSING PIECE WAS FOUND AT THE BOTTOM OF THE PATIENT'S CHEST. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378772 ↗
• MalfunctionOct 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), THE CANNULA HAD BROKE. THERE WAS NO PA TIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026601 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Environmental Particulates; Detachment of Device or Device Component; Environmental Particulates

  ACCORDING TO THE REPORTER PRIOR TO USE, THE POWDER OR PIECE COMES OFF FROM THE TOP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960676 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Environmental Particulates; Detachment of Device or Device Component; Environmental Particulates

  ACCORDING TO THE REPORTER PRIOR TO USE, THE POWDER OR PIECE COMES OFF FROM THE TOP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960625 ↗
• InjuryApr 22, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER POST OPERATIVE A COMPLETE MACROSCOPIC EXERESIS OF A CYSTIC LUMP OF THE LEFT POSTERIOR MEDIASTINUM USING THORACOSCOPY, AFTER 4 DAYS WHEN A EXPLORATORY LEFT THORACOTOMY FOR MEDIASTINITIS WAS BEING PERFORMED ON THE SAME PATIENT A SMALL PLASTIC PART WAS FORTUITOUSLY FOUND AND RETRIEVED, WHICH LOOKS LIKE A PART OF THE SINGLE USE PORT IN THE PROCEDURE PERFORMED 4 DAYS EARLIER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9989005 ↗
• MalfunctionMar 20, 2020Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER DURING A THORACO PNEUMOTHORAX PROCEDURE, THE SLIDING BETWEEN THE SLEEVE AND THE OBTURATOR WAS NOT SMOOTH. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860543 ↗
• MalfunctionMar 8, 2020Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER DURING A THORACO PNEUMOTHORAX PROCEDURE, THE SLIDING BETWEEN THE SLEEVE AND THE OBTURATOR WAS NOT SMOOTH. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9803990 ↗
• InjuryJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) THORACIC PROCEDURE, SMALL GREEN PIECES OF MATERIAL WERE COMING OUT OF THE BOTTOM OF THE TROCAR AND FELL INTO THE PATIENT CAVITY. THE SURGEON TRIED TO REMOVE ALL THE SMALL PIECES IN THE CAVITY, BUT IT WAS SO SMALL THAT THE SURGEON COULD NOT CONFIRM IF ALL THE PIECED WERE REMOVED AND THE SURGEON MOVED FORWARD WITH THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8287730 ↗
• MalfunctionOct 8, 2018Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER PRIOR TO A LOBECTOMY, WHEN PREPARING THE DEVICE A CRACK AT THE TIP OF THE PRODUCT WAS CONFIRMED. THEY STOPPED USING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7944370 ↗
• MalfunctionJan 12, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE¿S CANNULA BROKE WHEN THEY INSERTED THE TROCAR. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187626 ↗
• MalfunctionApr 17, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY, THE CANNULA BROKEN. A PART OF THE PORT FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6497131 ↗