VersaStep Plus VS101015PRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10884521082847), received between Jun 2, 2017 and Mar 19, 2026 — classified as 6 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (31 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BARIATRIC SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS (SADI), TOWARDS THE END OF THE CASE, THE DISTAL PIECE AT THE END OF THE TROCAR WAS FOUND BROKEN OFF. A THOROUGH EXPLORATORY LAPAROSCOPY WAS PERFORMED BUT THE SURGEON WAS UNABLE TO LOCATE THE BROKEN PIECE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

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

  MAUDE report 24640632 ↗
• MalfunctionSep 3, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY LAPAROSCOPIC PROCEDURE, AT THE INSTRUMENT EXCHANGE STEP, THE DEVICE WAS FOUND TO BE EXCESSIVELY LEAKING GAS AND HAD A DAMAGED SEAL. ANOTHER TROCAR WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952483 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN PLACING INSTRUMENTS IN AND OUT OF THE PATIENT THROUGH THE TROCAR, THE SILICONE PIECE ON THE LID OF THE TROCAR EITHER FELL OFF OR GOT STUCK IN THE LID OF THE TROCAR. NO PIECE FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, THE DEVICE HAD TO BE DISASSEMBLED TO GET IT OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002384 ↗
• MalfunctionSep 13, 2023Break; Difficult to Insert; Noise, Audible; Break; Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN INSERTING A COMPETITORS DEVICE INTO THE TROCAR, TO DISSECT AROUND FUNDUS OF THE STOMACH, IT WAS MAKING A STRANGE NOISE, AS IT WAS REPORTED THAT THE EDGE OF THE TROCAR WAS RUBBING AGAINST THE INSTRUMENTS THEY WERE PASSING THROUGH IT, DAMAGING THE SHAFTS OF THE INSTRUMENTS. THEY ALSO DID HAVE AN ISSUE WITH THE TROCAR PIERCING THROUGH THE RADIALLY EXPANDABLE SLEEVE AT AN ANGLE SO IT DIDN'T PERFORM AS IT SHOULD. THE SURGEON CONTINUED USING THE DEVICE UNTIL THE END OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738085 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC CYSTECTOMY PROCEDURE, A COUPLE OF PIECES CAME LOOSE FROM THE CANNULA AND FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED WITH A GRASPER, AND NO COMPONENTS WERE RETAINED IN THE PATIENT CAVITY. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16772229 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC SLEEVE GASTRECTOMY, THE SEAL OF THE TWO TROCAR REDUCER CAP CAME OFF AT THE START OF THE PROCEDURE. A THIRD TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548195 ↗
• MalfunctionFeb 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, AT INSERTION OF INSTRUMENT INTO PORT, THE SEAL DISENGAGED. THE SURGEON CONTINUED PROCEDURE AS IS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386328 ↗
• MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF A ROBOTIC LAPAROSCOPIC CYSTECTOMY AND BRICKER OPERATION, WHEN THE SURGEON PUT IN THE DEVICE A LITTLE PIECE FROM THE TIP OF THE CANNULA CAME LOOSE. IT WAS NOTED THAT THE SIZE IS 5X5MM. THIS WAS OBSERVED ON TWO DEVICES. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16118052 ↗
• MalfunctionNov 11, 2022Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING PROCEDURE, THE END OF CANNULA BROKE DURING INSERTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785471 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE CASE GROMMET (SEAL) DISLODGED AND FELL INTO THE PATIENT'S CAVITY. THE SURGICAL TIME WAS EXTENDED TO PICK UP THE LOOSE PART FROM THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552459 ↗
• MalfunctionSep 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF A ROBOTIC LAPAROSCOPIC CYSTECTOMY AND BRICKER OPERATION, WHEN THE SURGEON PUT IN THE DEVICE, A LITTLE PIECE FROM THE TIP OF THE CANNULA CAME LOOSE. IT WAS NOTED THAT THE SIZE IS 5X5MM. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505590 ↗
• MalfunctionSep 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE, THROUGHOUT THE CASE, THE GROMMET ON THE OUTSIDE OF THE PORT DISLODGED AND FELL INTO THE PATIENT'S CAVITY. COLLECTED THE PART THAT FELL IN THE CAVITY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15379517 ↗
• MalfunctionAug 23, 2022Detachment 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 A PROCEDURE, THE SEAL WAS DAMAGED. THE SEAL FELL INTO THE PATIENT CAVITY. THE SURGEON PICK IT UP TO RESOLVE THE ISSUE.

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

  MAUDE report 15279080 ↗
• InjuryJun 21, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE APART IN THE PATIENT. ATTEMPTS WERE MADE TO REMOVE THE PLASTIC PIECES WITHOUT SUCCESS. IT WAS NOTED THAT THE DEVICE WERE NOT X-RAY DETECTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14758004 ↗
• MalfunctionJun 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, A PIECE OF THE DISTAL TROCAR CANNULA BROKE OFF AND WAS FOUND IN THE ABDOMEN DURING INSPECTION PRIOR TO CLOSURE. TO RESOLVE THE ISSUE, THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714627 ↗
• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SURGEON FOUND TWO SMALL PIECES FROM THE CANNULA IN THE PATIENT'S CAVITY DURING ROBOTIC LAPAROSCOPIC CYSTECTOMY. THE TWO PIECES WERE RETRIEVED USING GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229697 ↗
• MalfunctionMar 10, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC CYSTECTOMY, A SMALL PIECE OF THE CANNULA BROKE AND FELL INTO THE PATIENT'S CAVITY, BUT IT WAS RETRIEVED THROUGH A TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453918 ↗
• MalfunctionOct 31, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED RADICAL PROSTACTECTOMY, THE 15MM TROCAR CHIPPED AT THE TIP PRIOR TO INSERTION OF ABDOMEN.

  Patient problems: No Information

  MAUDE report 10767181 ↗
• MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE PUTTING IN THE STAPLER, PART OF THE SEAL FELL INTO THE PATIENT DURING SURGERY AND IT WAS RETRIEVED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10523485 ↗
• MalfunctionApr 8, 2020Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, WHEN USING THE DEVICE INTO ABDOMEN, THE CANNULA, OBTURATOR, TROCAR BROKE AND THEY HAD TO FIND ALL OF THE MISSING PIECES WITHIN THE ABDOMEN AND WERE RETRIEVED BY A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935602 ↗
• MalfunctionJan 27, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, DURING REMOVAL OF SPECIMEN, THE CANNULA OF THE DEVICE BROKE. SURGEON NOTICED THAT DISTAL TIP OF CANNULA WAS BROKEN WHEN IT WAS REMOVED. IT WAS LIKELY THAT THE REASON FOR THE SPLITTING WAS MOST LIKELY DUE TO THE LAPAROSCOPIC SUTURE PASSER HITTING THE END OF THE TROCAR BECAUSE THE TROCAR WAS BEING USED AS A GUIDE. NOTHING WAS DONE TO RESOLVE THE ISSUE FOR IT WAS NOTED WHEN THE EVENT WAS OVER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9634934 ↗
• MalfunctionDec 5, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING ROBOTIC CYSTECTOMY, THE SEAL WAS DAMAGED AND WAS FOUND INSIDE THE ABDOMEN. THIS COULD BE SEEN BY THE EYE AND WAS ABLE TO BE RETRIEVED. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9421153 ↗
• MalfunctionNov 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO THE END OF A ROBOTIC GASTRIC SLEEVE PROCEDURE, IT WAS DISCOVERED THAT A CANNULA FLIP TOP CONVERTER WAS DISCONNECTED FROM THE CAP AND ACCIDENTALLY PUSHED INTO THE PATIENT'S ABDOMINAL CAVITY. THE DEVICE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Information

  MAUDE report 9282858 ↗
• MalfunctionSep 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INSTRUMENT EXCHANGE ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SEAL OF THE DEVICE DISENGAGED. IT WAS STATED THAT THE SEAL FELL OFF OUTSIDE OF THE PATIENT. ANOTHER UNIT WAS OPENED, HOWEVER THE SECOND UNIT HAD THE SAME ISSUE TOWARD THE END OF THE DISSECTION. A REDUCER WITH THE STAPLER WAS NOT NEEDED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8967735 ↗
• MalfunctionSep 3, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE, UPON USING THE DEVICE TROCAR, IT WAS NOTED THAT THE SLIDING BETWEEN THE DILATOR AND THE CANNULA WAS NOT SMOOTH AND THE DILATOR WAS NOT INSERTED SMOOTHLY. WHEN THE SURGEON INSERTED THE DEVICE TO THE TROCAR IN ORDER TO REMOVE THE SPECIMEN IT COULD NOT BE INSERTED DUE TO INSUFFICIENT LUBRICATION AND STUCK IN THE LOWER SEAL AND THE SHAFT TIP WAS SLIGHTLY TURNED UP. THEY APPLIED A LARGE AMOUNT OF STERILE JELLY TO THE LOWER SEAL AND SPREAD THE STERILE JELLY EVENLY WITH THE DILATOR. AFTER IMPROVING THE LUBRICATION EFFECT, THE DEVICE WAS INSERTED AGAIN. ALTHOUGH THERE WAS A LITTLE STRANGE FEELING, THE SPECIMEN WAS SUCCESSFULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8954539 ↗