VersaStepRecalls & reported problems across all models

We found 7 models of VersaStep by Covidien LP in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2017 and Jun 9, 2025 — classified as 6 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VersaStep problems

VersaStep models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VersaStep VS101005

  Laparoscope, general & plastic surgery
  128 reports
• VersaStep VSR100005

  Laparoscope, general & plastic surgery
  5 reports
• VersaStep VS100705

  Laparoscope, general & plastic surgery
  4 reports
• VersaStep VS101000

  Laparoscope, general & plastic surgery
  4 reports
• VersaStep VS070000

  Laparoscope, general & plastic surgery
  3 reports
• VersaStep VS101505

  Laparoscope, general & plastic surgery
  1 report
• VersaStep VS101500

  Laparoscope, general & plastic surgery
  1 report

Recent VersaStep adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR RAPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO P ATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760803 ↗
• 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 ↗

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