Step S100712Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20884521090672), received between Mar 8, 2019 and Dec 11, 2023 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE TROCAR INTO THE PATIENT, A PIECE OF PLASTIC FROM THE TROCAR BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON RETRIEVED THE PLASTIC PIECE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304981 ↗
• MalfunctionNov 10, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VIDEO-ASSISTED THORACOSCOPIC SURGERY WITH LEFT APICAL WEDGE RESECTION, APICAL PLEURECTOMY, AND SIDEWALL PLEURODESIS, THE TIP OF THE TROCAR CRACKED AND BROKE OFF INSIDE THE PATIENT. THE STAFF IN THE ROOM WAS THINKING THAT THE LAPAROSCOPIC STAPLER USED MAY HAVE CAUSED THE INITIAL DAMAGE TO THE TROCAR AND CREATED A CRACK OR WEAK SPOT TOWARDS THE TIP OF THE TROCAR. THE STAPLER DEVICE WAS NOT BROUGHT BACK INTO ALIGNMENT WITH THE SHAFT BEFORE TRYING TO BE WITHDRAWN THROUGH THE TROCAR. A COUPLE OF ATTEMPTS TO BRING THE STAPLER OUT WERE DONE WITH RESISTANCE BEFORE IT WAS REALIZED THE JAW OF THE STAPLER WAS STILL COCKED AT AN ANGLE. ONCE THE STAPLER WAS STRAIGHTENED OUT AND REMOVED A LAPAROSCOPIC INSTRUMENT WITH AN ELECTROSURGERY DEVICE SCRATCH PAD WRAPPED AROUND THE TIP AND PLACED INTO THE TROCAR. THE INSTRUMENT WAS THEN PASSED THROUGH THE TROCAR WITH EASE, AND IT WAS DISCOVERED THAT THE TIP OF THE TROCAR WAS BROKEN, DANGLING AROUND THE SHAFT OF THE INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115875 ↗
• MalfunctionSep 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WITH APICAL LUNG RESECTION AND PLEURODESIS, WHILE THE STAPLER WAS DOWN ON THE TROCAR, WHEN THE SURGEON PULLED OUT THE STAPLER, THE TROCAR BROKE INSIDE AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE TROCAR PART THAT FELL. IT WAS ALSO REPORTED THAT THERE WAS MINIMAL TISSUE DAMAGE DUE TO THE ISSUE. THE INCISION WAS EXTENDED DUE TO THE ISSUE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 17715746 ↗
• MalfunctionDec 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE TWO EXPANDABLE SLEEVES RIPPED OFF AND SEPARATED FROM THE PLASTIC PART. THE PIECES HAD TO BE RETRIEVED AND REMOVED FROM ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933845 ↗
• MalfunctionDec 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE TWO EXPANDABLE SLEEVES RIPPED OFF AND SEPARATED FROM THE PLASTIC PART. THE PIECES HAD TO BE RETRIEVED AND REMOVED FROM ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933797 ↗
• MalfunctionOct 25, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DEVICE WAS INTRODUCED, 1/3 OF THE BOTTOM CANNULA PORTION BROKE OFF AND FALL INTO THE CHEST CAVITY. THE BROKEN PIECE WAS RETRIEVED. TO RESOLVE THE ISSUE, THE DEVICE WAS REMOVED AND A TROCAR OF A DIFFERENT TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668229 ↗
• MalfunctionOct 18, 2022Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE PORT WAS INTRODUCED, THE BOTTOM 1/3 OF THE DEVICE BROKE OFF INTO THE CHEST CAVITY. THE PORT WAS REMOVED AND A NEW PORT WAS PLACED. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626041 ↗
• MalfunctionNov 29, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, UPON INSERTION, THE OBTURATOR/TROCAR BROKE. OPENED ANOTHER TROCAR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12881766 ↗
• InjuryOct 6, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WITH PLEURODESIS TO REMOVE BLEBS AND REPAIR PNEUMOTHORAX AND WAS DISCHARGED. THE RECOVERY AT HOME DID NOT PROCESS AS EXPECTED. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND DEMANDED A COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH REVEALED A RECTANGULAR ARTIFACTUAL TUBULAR DENSITY IN THE LEFT LUNG BASE. IT WAS D ISCOVERED THAT THE 12MM TROCAR HAD BROKEN OFF IN THE PATIENT'S CHEST CAVITY AND A 1" PIECE REMAINED AFTER THE SURGERY WAS COMPLETED AND THE PATIENT WAS SENT HOME. 17 DAYS POST-OPERATIVELY OF THE INITIAL PROCEDURE, THERE WERE OTHER FRAGMENTS THAT WERE EMBEDDED IN THE LUNG TISSUE THAT WERE DISCOVERED DURING THE OPERATION IN A SUBSEQUENT CT SCAN WHICH REMAINED IN THE PATIENT'S LUNG. THE PATIENT EXPERIENCED NUMEROUS SYMPTOMS WHICH INDICATED THAT THERE WAS A POST-OPERATIVE ISSUE REMAINING. THE EMERGENCY PROCEDURE WAS PERFORMED TO REMOVE THE PIECE OF TROCAR AND THE PATIENT'S LUNG HAD COLLAPSED AND THE TOP PORTION OF THE LUNG WAS REMOVED. WHEN THE TROCAR PIECE WAS DISCOVERED, A SECTION OF THE LOWER LUNG WAS TAKEN OUT. THE SURGICAL TIME WAS INCREASED BY 30 MINUTES OR MORE AND THE INCISION WAS EXTEND

  Patient problems: Foreign Body In Patient; Impaired Healing; Pneumothorax; Respiratory Insufficiency; Unintended Radiation Exposure

  MAUDE report 12582539 ↗
• InjuryAug 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TROCAR WAS BREAKING OFF INSIDE OF THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 12294182 ↗
• MalfunctionAug 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY, AT THE END OF THE CASE, IT WAS DISCOVERED THAT THE TROCAR HAD BROKEN. THE CANNULA WAS BROKEN AND PIECE OF THE DEVICE FELL INTO THE CAVITY OF THE PATIENT WAS TAKEN OUT. IT WAS GRABBED UNDER DIRECT VISUALIZATION AND REMOVED FROM PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293603 ↗
• InjuryMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOTIC NEPHRECTOMY, WHEN THE SURGEON PLACED A CLIP APPLIER INTO A 12MM PORT WITH CANNULA SEAL, THE RUBBER PART WAS PUSHED INTO THE PATIENT'S ABDOMEN AND BLEEDING WAS OBSERVED. AFTER THE BLEEDING WAS UNDER CONTROL, THE SURGEON AND THE ALL PERSONNEL IN THE ROOM SEARCHED FOR THE RUBBER PIECE FOR OVER AN HOUR. THEN, IT WAS CONVERTED TO LAPAROSCOPIC TO FURTHER LOOK FOR THE PIECE, BUT NO AVAIL. SO, THE SURGEON CLOSED THE WOUNDS WITHOUT FINDING THE PIECE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9792606 ↗
• InjuryFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEAL DISENGAGED AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON COULD NOT FIND IT AFTER AN HOUR OF SEARCHING IN THE ABDOMINAL CAVITY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9706893 ↗
• MalfunctionDec 5, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE OBTURATOR AND CANNULA WAS BEING INSERTED, THE DISTAL TIP OF THE DEVICE BROKE OFF THE RADIALLY EXPANDING SLEEVE THROUGH THE ABDOMINAL WALL AND DISENGAGED INTO THE PATIENT'S CAVITY. THIS WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. SAME DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417090 ↗
• MalfunctionJul 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHILE INSERTION OF DEVICE INTO THE ABDOMINAL WALL, A PIECE OF THE SLEEVE CAME OFF AND ENDED UP INSIDE THE PATIENT. IT IS THE PLASTIC TIP THAT COVERS THE EXPANDABLE SLEEVE ITSELF (IT'S NOT THE SHEATH THAT COMES OVER THE SLEEVE, IT'S THE PIECE ON THE SLEEVE ITSELF THAT KEEPS THE EXPANDABLE FIBERS TOGETHER). THE SURGEON WAS ABLE TO RETRIEVE ALL PLASTIC PARTS FROM THE ABDOMEN PRIOR TO CONTINUING WITH THE PROCEDURE USING A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776238 ↗
• MalfunctionJun 4, 2019Break; Break

  ACCORDING TO THE REPORTER, THE EXPANDABLE SLEEVE FAILED TO EXPAND AND HAD INTERNAL DAMAGE NOT VISIBLE TO THE SURGEON. THEY REMOVED THE INSTRUMENT AND GOT ANOTHER ONE LIKE IT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668961 ↗
• MalfunctionMar 29, 2019Difficult to Remove; Packaging Problem; Difficult to Remove; Packaging Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE RUBBER PART WAS RIPPED THAT CAUSED DIFFICULTY OF REMOVING THE DEVICE FROM THE ABDOMEN. THEY MANGE TO REMOVE THE DEVICE AND USED A STAPLER TO CLOSE THE SKIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464432 ↗
• MalfunctionMar 8, 2019Break; Difficult to Insert; Difficult to Remove; Break; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE DEVICE INTO THE LEFT CHEST. IT DID NOT GO IN EASILY AND THE SKIN INCISION WAS EXTENDED BY 1-2 MM. THE DEVICE FUNCTIONED AS INTENDED FOR THE DURATION OF THE PROCEDURE. HOWEVER, AT THE CONCLUSION OF THE CASE, WHEN THE SURGEON PULLED THE PORT TO REMOVE IT FROM THE CHEST WALL, THE GRAY SHAFT OF THE PORT BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405053 ↗