ENDOPATH TT012Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705036013372), received between Mar 5, 2018 and Oct 16, 2024 — classified as 6 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Crack” (26 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

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A RIGHT THORACOSCOPY VIDEO THROUGH TWO 12 MM THORACOPPORTS AT THE 5TH INTERCOSTAL SPACE, A 12 MM SURGICAL TROCAR IS USED. WHEN THE CAMERA IS INSERTED, THE TROCAR IS DAMAGED AND BREAKS INTO SEVERAL FRAGMENTS. THE OPERATOR ATTEMPTS TO REMOVE THE FRAGMENTS IN THE PATIENT¿S CHEST. AFTER RECONSTITUTION OF THE TROCAR WITH THE FRAGMENTS RECOVERED IN THE PATIENT'S CHEST AND ON THE OPERATING FIELD, IT IS FOUND THAT SEVERAL FRAGMENTS ARE MISSING. PROLONGED PROCEDURE 30 MINUTES POSSIBLE PRESENCE OF FRAGMENTS IN THE PATIENT¿S CHEST. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR PATIENT CARE: SEARCHING FOR FRAGMENTS OF THE TROCAR ON THE SURGICAL FIELD AND IN THE PATIENT¿S CHEST, REMOVING CERTAIN PLASTIC FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20465119 ↗
• MalfunctionAug 27, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY VATS, THE TIP OF THE TROCAR WAS BROKEN. IT WAS USED ON LUNG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076610 ↗
• MalfunctionAug 22, 2024Crack; Crack

  IT WAS REPORTED THAT DURING THORACOSCOPIC PNEUMONECTOMY, GROOVE SECTION DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041530 ↗
• MalfunctionJul 10, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A VATS RIGHT LOWER LOBECTOMY, TROCAR WAS CRACKED AFTER VIEWING IT INSIDE THE PATIENTS THORACIC CAVITY VIA THE LAPAROSCOPIC CAMERA. THROUGH OUT THE SURGERY THIS TROCAR WAS REMOVED AND REINSERTED NUMEROUS TIMES. DID NOT NOTICE ANY CRACKING DURING THIS PERIOD. THEREFORE, THEY STATED THAT THE CRACKING HAD TO HAD OCCURRED NEAR THE END OF THE PROCEDURE, THEY DO NOT RECALL A SINGULAR EVENT OCCURRING WHERE THE CRACKING COULD HAVE TAKEN PLACE. THE TROCAR WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE FIELD AND VISUALIZATION WAS DONE TO ENSURE NO REMAINING FRAGMENTS WERE RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713210 ↗
• MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857640 ↗
• MalfunctionDec 14, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE DEVICE BROKE WHEN USING. NO PIECE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326474 ↗
• MalfunctionApr 5, 2023Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE TROCAR COULD NOT BE LOCKED PROPERLY, AND IT WAS FOUND THAT TIP WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681807 ↗
• MalfunctionMar 14, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, A PART OF THE OUTER SEAL FELL OFF. THE FALLEN PART HAS BEEN RETRIEVED. THERE WAS TOO MUCH PRESSURE ON THE DEVICE. THE DEVICE WAS USED ON THE LUNG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539284 ↗
• MalfunctionDec 15, 2022Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY SURGERY, A PART OF THE TROCAR BROKE DURING USE. THE BROKEN PIECE HAS BEEN RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986574 ↗
• InjuryJun 2, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE DEVICE WAS BROKEN OFF WHEN IT WAS REMOVED FROM THE PATIENT. THERE IS A POSSIBILITY THAT A PIECE OF THE FRAGMENT WAS LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14574778 ↗
• InjuryJun 1, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A RESPIRATORY SURGERY, IT WAS FOUND THAT THE DEVICE HAD A HUGE DAMAGE WHEN CLOSING A SURGICAL INCISION. IT WAS OPENED AND A BROKEN PIECE WAS FOUND INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14565167 ↗
• InjuryApr 21, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LEFT LOBECTOMY, THE SLEEVE WAS BROKEN OFF WHILE A CAMERA WAS OPERATED AFTER THE DEVICE WAS USED FOR ABOUT 2 HOURS. THE DEVICE WAS USED ON THE MID-AXILLARY LINE IN THE 6TH. THE DEVICE WAS REMOVED FROM THE PATIENT AND CHECKED, THEN IT WAS FOUND THAT A 1MM FRAGMENT WAS LEFT INSIDE THE PATIENT. THE INTRATHORACIC LAVAGE WAS PERFORMED BUT IT COULD NOT BE FOUND. THE SURGEON THOUGHT IT IS NOT A PROBLEM BECAUSE IT WAS VERY SMALL. THE PROCEDURE WAS NOT CONVERTED. THE PATIENT¿S CONDITION IS STABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14169570 ↗
• MalfunctionApr 15, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE SLEEVE WAS BROKEN OFF WHEN THE TROCAR WAS REMOVED FROM THE PATIENT AFTER THE SURGERY. THE BROKEN PIECES WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119124 ↗
• MalfunctionMar 18, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS CRACKED DURING USE. NO PIECES WERE LEFT SIDE THE PATIENT. THE DEVICE WAS USE ON THE INTERCOSTAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803441 ↗
• MalfunctionMar 8, 2022Crack; Component or Accessory Incompatibility; Crack; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A SEMI-OPEN PNEUMONECTOMY, A STAPLER WAS INSERTED/REMOVED THROUGH THE TROCAR. IT GOT CAUGHT IN THE SLEEVE AND SLEEVE WAS BROKEN AND FELL INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED BY FORCEPS. THE PROCEDURE WAS NOT CONVERTED. THE DEVICE WAS USED ON THE LUNG. ANOTHER DEVICE (TROCAR) WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT¿S CONDITION IS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13701204 ↗
• MalfunctionMar 8, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A VATS PNEUMONECTOMY, THE TIP OF THE DEVICE WAS SEVERELY BROKEN WHEN A CAMERA WAS INSERTED THROUGH THE DEVICE AND USED. THE DEVICE WAS USED ON THE LUNG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691707 ↗
• MalfunctionFeb 1, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A RESPIRATORY SURGERY, THE DEVICE WAS BROKEN OFF. AN ENDOCAMELEON HOPKINS (KARL STORZ) WAS USED WITH THE DEVICE AND ITS BENDING PART DAMAGED THE DEVICE. THE SURGEON COMMENTED THAT A BROKEN PART MUST HAVE BEEN DISCHARGED BY SUCTION. THE CUSTOMER REPORTED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT¿S CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417528 ↗
• MalfunctionOct 6, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A VATS PNEUMONECTOMY, THE DEVICE WAS BROKEN OFF DURING USE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587297 ↗
• MalfunctionSep 22, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A VATS LOBECTOMY, THE PORT WAS BROKEN WHEN THE CAMERA WAS INSERTED THROUGH THE DEVICE. NO PIECES WERE LEFT INSIDE THE PATIENT. THE DEVICE WAS USED ON THE LUNG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516497 ↗
• MalfunctionJan 6, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A VATS PNEUMONECTOMY, THE TIP OF THE OUTER SLEEVE WAS BROKEN OFF WHEN A CAMERA WAS REMOVED THROUGH THE DEVICE. THE BROKEN PIECE HAD NOT FALLEN INTO THE PATIENT. THE CAMERA WAS A RIGID ENDOSCOPE. A PEAN DEVICE WAS USED TO MAKE A HOLE TO INSERT THE DEVICE INTO THE PATIENT EASILY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128533 ↗
• MalfunctionDec 16, 2020Crack; Crack

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, THE DEVICE WAS BROKEN OFF DURING USE. THE BROKEN PIECES FELL INTO THE PATIENT, BUT THEY WERE ALL RETRIEVED. THE BROKEN PIECE WAS RETRIEVED FROM THE SMALL INCISION WHICH WERE OPENED ALREADY. DOCTOR THOUGHT THE TROCAR WAS BROKEN WHEN THE FORCEPS WERE PRESSED TO THE TROCAR IN THE NARROW AREA BETWEEN RIBS. THE DEVICE WAS USED ON THE LUNG. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024878 ↗
• MalfunctionDec 16, 2020Crack; Defective Component; Crack; Defective Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONE OF DEVICES WAS BROKEN OFF WHEN A CAMERA WAS REMOVED THROUGH IT. THE PROCEDURE WAS THORACOSCOPIC SURGERY FOR PULMONARY MALIGNANT TUMOR. THE TIP OF THE SLEEVE WAS BROKEN. THE BROKEN PIECES WAS RETRIEVED FROM THE PATIENT. DOCTOR THOUGHT THE TROCAR MAY BE BROKEN WHEN SANDWICHED BETWEEN THE CAMERA AND COSTA. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016978 ↗
• MalfunctionOct 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING VIDEO-ASSISTED THORACOSCOPIC EXPLORATION OF LEFT THORACIC MEDIASTINUM, NOTED THAT THE TROCAR SLEEVE WAS BROKEN INTO FEW PARTS DURING THE FIRING. ALL PARTS HAVE BEEN REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10636424 ↗
• MalfunctionAug 20, 2020Material Separation; Material Separation

  IT WAS REPORTED BY THAT DURING A RESPIRATORY SURGERY, THE TROCAR SLEEVE OF THE DEVICE BROKE. THE BROKEN PIECES WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434760 ↗
• MalfunctionAug 12, 2020Crack; Crack

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC LOBECTOMY, CRACKS WERE NOTED ON THE TROCAR. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE COULD NOT BE RETURNED BECAUSE THE PATIENT HAD AN INFECTIOUS DISEASE NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395655 ↗