VersaStep Plus VS101012PRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521082885), received between Sep 7, 2017 and Sep 15, 2026 — classified as 10 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  It was reported that during a procedure, the mesh of the trocar cannula was broken. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766497 ↗
• MalfunctionMar 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, A PIECE OF THE TROCAR BROKE INSIDE THE PATIENT. THE TROCAR PIECE WAS RETAINED IN THE PATIENT AND SUBSEQUENTLY RETRIEVED DURING THE PROCEDURE. VISUALIZATION WAS USED TO IDENTIFY AND RETRIEVE THE BROKEN TROCAR PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712536 ↗
• MalfunctionJul 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE SEAL OF THE DEVICE WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629227 ↗
• MalfunctionJul 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE EXPANDABLE SLEEVE BROKE AFTER THE ACCESS NEEDLE WAS INSERTED AND THE CANNULA WAS PLACED, RENDERING THE DEVICE UNUSABLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412209 ↗
• InjuryMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC 3-HOLE ESOPHAGECTOMY USING THE DEVICE, PART OF THE CANNULA BROKE OFF AND FELL INTO THE PATIENT WHILE MOBILIZING THE CONDUIT. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT, BUT THE PIECE OF THE TROCAR CANNULA WAS LEFT IN THE PATIENT. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE, SIGNIFICANT BLOOD LOSS, OR EXTENSION OF SURGICAL TIME OR INCISION DUE TO THE PRODUCT PROBLEM. THE PROCEDURE WAS CONTINUED AFTER THE X-RAYS WERE TAKEN, AND NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21694399 ↗
• MalfunctionOct 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RESECTION OF A TUMOR OF THE UTERINE ADNEXA, THE CANNULA RUPTURED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409785 ↗
• MalfunctionSep 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY TO ROUX-EN-Y CONVERSION, THE RADIALLY EXPANDABLE SLEEVE TORE AND WAS STUCK ON THE END OF THE TROCAR. IT SEEMED AS THOUGH THERE WAS NO HOLE MADE IN THE TIP OF THE RADIALLY EXPANDABLE SLEEVE. THE SURGEON HAD TO USE TROCAR WITHOUT THE SLEEVE IN ORDER TO USE GRASPERS AND DEVICES IN THAT TROCAR SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267390 ↗
• MalfunctionJul 9, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE TWO SMALL PIECES OF THE OUTER SHEATH OF THE CANNULA WERE SHREDDED OUTSIDE THE PATIENT'S CAVITY. THE SHREDDING WAS RETRIEVED. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706669 ↗
• MalfunctionMar 21, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN REMOVING A DEVICE FROM OTHER MANUFACTURER FROM ABDOMEN THROUGH TROCAR, THE SEAL WAS DAMAGED AND THE SEAL DISENGAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956048 ↗
• MalfunctionJan 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN ENTERING THE 12MM STAPLER IN THE TROCAR, THE RADIAL EXPANDABLE SLEEVE BROKE. THE TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440607 ↗
• MalfunctionOct 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROSTATECTOMY, THE TROCAR WAS INSERTED CORRECTLY BY THE SURGEON, THEN AFTER INSERTING INSERTING THE INSTRUMENT, THE SLEEVE WAS TORN, THE UPPER AND LOWER PART WAS CUT. PART OF THE SLEEVE ENDED UP IN THE PATIENT'S ABDOMEN. THE DETACHED PIECE OF THE DEVICE WAS REMOVED. THE SURGICAL TIME WAS EXTENDED BY NO MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909611 ↗
• MalfunctionAug 8, 2023Break; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SEAL WAS DAMAGED. THE HEAD OF THE CANNULA BROKE INTO SEVERAL PIECES UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481652 ↗
• MalfunctionApr 20, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A FAULTY DEVICE, AND THE NETTING ON THE PORT CANNULA WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 16776833 ↗
• MalfunctionFeb 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, AT TROCAR INSERTION, THE SCOPE THAT THE DISTAL END OF THE CANNULA WAS CHIPPED AND THE PIECE HAD TO BE RETRIEVED IN THE CAVITY. THE PIECE WAS REMOVED AND TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428044 ↗
• MalfunctionDec 6, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CANNULA BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928370 ↗
• MalfunctionDec 6, 2022Break; Break

  ACCORDING TO THE REPORTER, THE CANNULA BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927685 ↗
• MalfunctionAug 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE TROCAR WAS INSERTED, PART OF THE EXPANDABLE SLEEVE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214204 ↗
• MalfunctionAug 10, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE TROCAR WAS INSERTED, THE EXPANDABLE SLEEVE BROKE. SINCE THE USER DID NOT NOTICE WHEN THE PACKAGE WAS OPENED, THE OPERATOR DID NOT KNOW IF IT BROKE AT THAT MOMENT. PART OF THE SLEEVE HAD BROKEN WHEN PUNCTURE WAS PERFORMED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200799 ↗
• 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 15161627 ↗
• MalfunctionMar 2, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE THE TROCAR BROKE. IT DID NOT FIT IN THE CANNULA. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654284 ↗
• MalfunctionFeb 28, 2022Difficult to Insert; Noise, Audible; Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, ON PORT INSERTION, THE DEVICE MADE A STRANGE NOISE, THE PORT WOULD NOT FIT INTO THE SLEEVE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625893 ↗
• MalfunctionJan 5, 2022Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE SETTING UP, THE OBTURATOR WOULD NOT FIT INTO THE CANNULA OF 2 TROCARS. THE CANNULAS WERE DETACHED FROM THE TOP PORTION OF THE PORT. ANOTHER DEVICE FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169167 ↗
• MalfunctionNov 15, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, WHEN THE SURGEON PULLED OUT THE SLEEVE IT LOOKED COMPLETELY DEFORMED. THE SLEEVE STOCKING LACED UP AND WAS SPLIT. THE SURGEON THEN TOOK OUT THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811683 ↗
• MalfunctionNov 15, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE SURGEON PULLED OUT THE SLEEVE FROM THE PATIENT IN A ROBOTIC LAPAROSCOPIC BRICKER (UROLOGY) PROCEDURE, THE SLEEVE ON THE PATIENT WAS LACED UP AND WAS SPLIT. THE SLEEVE WAS COMPLETELY DEFORMED. SURGEON SUTURED THE WOUND TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810908 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, LAPAROSCOPIC INGUINAL HERNIA REPAIR, A PIECE OF THE TOP PLASTIC PART OF THE TROCAR SLEEVE BROKE OFF AND LANDED IN THE ABDOMEN OF THE PATIENT. THE SURGEONS FOUND THE LITTLE PIECE DURING THE LAST OPTICAL CHECK AROUND INSIDE THE PATIENT PRIOR TO PULLING OUT TROCARS AND CLOSING THE PORT HOLES. THE TROCAR PIECE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819332 ↗