VersaStep VS101005Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 20884521082837), received between Mar 31, 2017 and Jun 9, 2025 — classified as 4 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (52 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 128 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL OPERATION, THE CANNULA DROPPED AND COULD NOT BE FOUND IN THE PATIENT'S CAVITY. IT WAS NOTED THAT IN ORDER TO FIND THE DAMAGED PART, THE PORT INCISION WAS EXTENDED BY 5MM AND THE INCISION WAS MADE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. WHEN THE USER CHECKED THE VIDEO AFTER THE OPERATION, THE DEVICE WAS DISCOVERED TO BE DAMAGED AT THE TIME OF INSERTION.

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 22172959 ↗
• MalfunctionApr 19, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE TWO INSTRUMENTS WERE GETTING STUCK IN THE TROCARS. ALL SURGICAL DEVICES HAD TO BE LUBED UP IN ORDER TO EASILY GET THROUGH THE TROCARS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146912 ↗
• MalfunctionJan 23, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y, WHEN THE TROCAR WAS BEING PLACED IN ABDOMEN FOR ACCESS, THE TROCAR WAS BEING STICKIER THAN USUAL AND NEEDS MORE LUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566782 ↗
• MalfunctionNov 27, 2023Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN TAKING THE INSTRUMENTS IN AND OUT OF THE PORT, THE SURGEON FELT THAT THE TROCAR WAS GRIPPING THE 5MM GRASPER TOO TIGHT WHICH WAS NOT ALLOWING THE GRASPER TO MOVE IN THE PORT. THE SURGEON WAS ALSO HAVING AN ISSUE GETTING INSTRUMENTS IN AND OUT OF THE PORT. THE DEVICE WAS CONTINUED TO BE USED DESPITE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211461 ↗
• MalfunctionJul 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, AT THE TIME OF INSERTING THE TROCAR TO BEGIN THE PROCEDURE, THE TIP OF THE CANNULA CRACKED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375262 ↗
• InjuryMay 15, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TUBAL LIGATION, WHEN THE SURGEON REMOVED THE TROCAR SHEATH FROM THE ABDOMEN, IT WAS NOTED BY THE SURGEON THAT THE TIP (APPROXIMATELY 2 CENTIMETER) OF THE SHEATH APPEARED TO BE MISSING. THE SECOND TROCAR USED ALSO APPEARED TO BE MISSING ABOUT A 3.5 CENTIMETER SEGMENT OF THE DISTAL TIP UPON REMOVAL. EXPLORATORY LAPAROTOMY ALONG WITH COMPUTED TOMOGRAPHY (CT SCAN) WERE COMPLETED IN AN ATTEMPT TO LOCATE THE ALLEGED MISSING PIECES, HOWEVER, NONE COULD BE DETECTED. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE TWO TROCARS USED IN THE PROCEDURE WERE INTACT AND NO FRAGMENTS HAD ACTUALLY BEEN RETAINED. THE SECOND SHEATH ON BOTH DEVICES HAD APPARENTLY RETRACTED WITHIN ITSELF.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16935244 ↗
• InjuryMay 15, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TUBAL LIGATION, WHEN THE SURGEON REMOVED THE TROCAR SHEATH FROM THE ABDOMEN, IT WAS NOTED BY THE SURGEON THAT THE TIP (APPROXIMATELY 2 CENTIMETER) OF THE SHEATH APPEARED TO BE MISSING. THE SECOND TROCAR USED ALSO APPEARED TO BE MISSING ABOUT A 3.5 CENTIMETER SEGMENT OF THE DISTAL TIP UPON REMOVAL. EXPLORATORY LAPAROTOMY ALONG WITH COMPUTED TOMOGRAPHY (CT SCAN) WERE COMPLETED IN AN ATTEMPT TO LOCATE THE ALLEGED MISSING PIECES, HOWEVER, NONE COULD BE DETECTED. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE TWO TROCARS USED IN THE PROCEDURE WERE INTACT AND NO FRAGMENTS HAD ACTUALLY BEEN RETAINED. THE SECOND SHEATH ON BOTH DEVICES HAD APPARENTLY RETRACTED WITHIN ITSELF.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16935215 ↗
• MalfunctionApr 28, 2023Break; Noise, Audible; Break; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE ACCESS NEEDLE WAS SET INTO THE EXPANDABLE SLEEVE, AND THE PUNCTURE WAS PERFORMED. THE ACCESS NEEDLE WAS PULLED OUT, AND A "BUZZ" SOUND HAS SOUNDED DURING INSERTION OF THE STEP PORT INTOTHE EXPANDABLE SLEEVE, SO THE EXPANDABLE SLEEVE WAS INCLUDED IN THE REMOVAL. IT WAS CONFIRMED THAT THIS TUBE WAS CRACKED, THERE WERE NO BROKEN OR CRACKED PARTS IN THE ABDOMINAL CAVITY. A NEW PRODUCT WAS USED TO ADDRESS THE SITUATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830036 ↗
• MalfunctionDec 2, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE L-HOOK WAS STUCK INSIDE THE TROCAR.

  Patient problems: Insufficient Information

  MAUDE report 15903747 ↗
• MalfunctionNov 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR/TROCAR BROKE.

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

  MAUDE report 15798168 ↗
• MalfunctionAug 31, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE RESECTION, WHEN PUNCTURING THE THIRD PORT, THE RELEVANT PRODUCT WAS USED AND THE OBTURATOR WAS INSERTED, AND WHEN PUNCTURED INTO THE PATIENT'S WOUND SITE, THE EXPANDER SLEEVE BROKE FROM THE DISTAL PART. A NEW PRODUCT WAS TAKEN OUT AND USED TO DEAL WITH THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329935 ↗
• MalfunctionAug 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SERVICING, WHEN CHECKING THE PRODUCTS RECEIVED AS THE REPLACEMENT DEVICES, THE CANNULAS WERE FOUND TO BE BROKEN. SOMETHING LIKE CRACK WAS FOUND ON THE SURFACE OF THE PROXIMAL PART OF THE SLEEVE AS THE SAME. A NEW PRODUCT WAS USED TO FIX THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259152 ↗
• MalfunctionAug 16, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SERVICING, 7 UNITS OF REPLACEMENT DEVICES WERE FOUND THAT THE CANNULA BROKE. A CRACKED WAS FOUND AT THE PROXIMAL SITE OF THE SLEEVE WHEN THE DISTRIBUTOR CHECKED THE FACILITY INVENTORY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235294 ↗
• MalfunctionAug 16, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SERVICING, 7 UNITS OF REPLACEMENT DEVICES WERE FOUND THAT THE CANNULA BROKE. A CRACKED WAS FOUND AT THE PROXIMAL SITE OF THE SLEEVE WHEN THE DISTRIBUTOR CHECKED THE FACILITY INVENTORY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235230 ↗
• MalfunctionAug 10, 2022Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC SURGERY, AFTER PUNCTURING THE TROCAR, THE MESH PATTERNS OF THE TWO SLEEVES WAS EXPOSED AND DAMAGED. THERE WERE CARBON DIOXIDE (CO2) LEAKED. IT WAS STATED THAT IT WAS DIFFICULT TO PERFORM THE OPERATION. ON THE COLLECTED UNUSED DEVICES WITH THE SAME LOT NUMBER, THE SALES REPRESENTATIVE FOUND OUT THAT IN THE BLISTER PACK, THERE WERE OBVIOUSLY CHIP. THERE WAS AN EXPOSED MESH AROUND THE BASE PART OF THE SLEEVE IN 2 OF THE 5 EXPANDABLE SLEEVES, AND SLEEVE MESH PATTERN WAS VISIBLE. TO RESOLVE THE ISSUE, ANOTHER TROCAR WAS USED. MEASURE WAS TAKEN TO DEAL WITH PNEUMOPERITONEUM LEAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201175 ↗
• MalfunctionAug 10, 2022Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC SURGERY, AFTER PUNCTURING THE TROCAR, THE MESH PATTERNS OF THE TWO SLEEVES WAS EXPOSED AND DAMAGED. THERE WERE CARBON DIOXIDE (CO2) LEAKED. IT WAS STATED THAT IT WAS DIFFICULT TO PERFORM THE OPERATION. ON THE COLLECTED UNUSED DEVICES WITH THE SAME LOT NUMBER, THE SALES REPRESENTATIVE FOUND OUT THAT IN THE BLISTER PACK, THERE WERE OBVIOUSLY CHIP. THERE WAS AN EXPOSED MESH AROUND THE BASE PART OF THE SLEEVE IN 2 OF THE 5 EXPANDABLE SLEEVES, AND SLEEVE MESH PATTERN WAS VISIBLE. TO RESOLVE THE ISSUE, ANOTHER TROCAR WAS USED. MEASURE WAS TAKEN TO DEAL WITH PNEUMOPERITONEUM LEAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201158 ↗
• MalfunctionAug 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGY PROCEDURE, WHEN TROCAR WAS PLACED ON THE ABDOMINAL WALL, THE CANNULA BROKE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161617 ↗
• MalfunctionAug 3, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, AT THE TIME OF INITIAL INSERTION OF TROCAR, THE 5MM SLEEVE WAS FOUND TO BE CHIPPED AND THE NET WAS FOUND TO BE BROKEN, FROM THERE, A LARGE AMOUNT OF PNEUMOPERITONEUM GAS LEAKED. THE SURGEON TOOK OUT A NEW PRODUCT AND TRIED, BUT ALL THE SAME ISSUE OCCURRED FROM THE SAME BATCH. AFTER CHECKING AND COMPARING THE PRODUCT THAT WAS FINE TO THE DEFECTIVE ONE, THE THIN FILM COVERING THE SLEEVE MESH PATTERNS WAS NOT ATTACHED FROM THE BEGINNING AND IT WAS CLEARLY FROM THE NORMAL PRODUCT. THE SURGEON USED A NEW DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157952 ↗
• MalfunctionMay 13, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SALPINGO, WHILE ADVANCING THE TROCAR INTO THE ABDOMINAL WALL THE SHEATH BROKE AND THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399740 ↗
• MalfunctionFeb 3, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TROCAR PUNCTURE ON A LAPAROSCOPIC ADNEXECTOMY, THE BLACK PART OF THE TROCAR CANNULA GOT BROKEN AND IT DROPPED INTO THE CAVITY AND WAS COLLECTED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440361 ↗
• MalfunctionNov 12, 2021Break; Break

  ACCORDING TO THE REPORTER PRIOR TO USE, WHEN THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE PLASTIC WRAP AROUND THE PROXIMAL PORTION OF THE RADIAL EXPANDABLE SLEEVE WAS RIPPED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805215 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DUODENAL SWITCH, THE DEVICE'S SEAL GOT DAMAGE AND DISENGAGED INTO THE PATIENT CAVITY. THE PIECES OF SEAL WERE LAPAROSCOPICALLY REMOVED WITH A GRASPER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137524 ↗
• MalfunctionApr 29, 2021Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE FIRST INSTRUMENT THAT WAS PLACED THROUGH THE TROCAR AND IT WAS NOTICED THAT IT WAS HAVING A VACCUM AFFECT IN THE TROCAR AND THE INSTRUMENT WAS GETTING STUCK. WHEN THE USER TRIED TO PULL IT OUT THE TROCAR WAS COMING OUT WITH IT. IT WAS NOT ABLE TO SLIDE AS EASILY IN AND OUT OF THE TROCAR. NOTHING WAS DONE TO RESOLVE THE ISSUE. THE OPERATOR KEPT USING THE SAME TROCAR JUST BEING AWARE THAT THE INSTRUMENTS MIGHT STICK A LITTLE IN THE TROCAR CAUSING IT TO CAME OUT WHEN TAKING THE DEVICE OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744904 ↗
• MalfunctionFeb 18, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BILATERAL TUBAL CYSTECTOMY, THE DEVICE CANNULA BROKE. IN ADDITION WHEN THE SURGEON INSERTING THE INSTRUMENT INTO THE TROCAR, A PLASTIC PIECE FROM THE TROCAR COMPONENT WAS FOUND AT INTO THE PATIENT CAVITY. THE SURGEON THEN ABLE TO REMOVED THE COMPONENT PIECE AND CONTINUE WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345358 ↗
• MalfunctionSep 15, 2020Break; Difficult to Insert; Difficult to Remove; Break; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY, THE FORCEPS WERE DIFFICULT TO PASS THROUGH THE PORT, THE TIP OF BLUNT DILATOR WAS FOUND TO BE CHIPPED IN THE CAMERA IMAGE AND DAMAGE WAS NOTICED. WHEN SEARCHED FOR THE FRAGMENT OF THE CHIPPED PART, IT WAS STUCK INTO THE DERMIS OF THE PORT INCISION. THE SURGEON FELT RESISTANCE WHEN INSERTING THE TROCAR. THE TROCAR WAS PULLED OUT AND THE CHIPPED PART WAS RETRIEVED WITH FORCEPS UNDER DIRECT VIEW. A NEW PRODUCT WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538352 ↗