Mini StepRecalls & reported problems across all models

We found 4 models of Mini Step by Covidien LP in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2017 and Apr 30, 2026 — classified as 7 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (68 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 Mini Step problems

Mini Step models

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

• Mini Step MS100705

  Laparoscope, general & plastic surgery
  91 reports
• Mini Step MS101005

  Laparoscope, general & plastic surgery
  5 reports
• Mini Step MS101008

  Laparoscope, general & plastic surgery
  5 reports
• Mini Step MS101003

  Laparoscope, general & plastic surgery
  1 report

Recent Mini Step adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, A PHYSICIAN NOTICED THAT A SMALL PIECE OF TROCAR BROKE OFF WHILE INSERTING THE DILATOR INTO THE PATIENT. IT WAS REPORTED THAT THE BROKEN PIECE FELL INTO THE PATIENT CAVITY, AND NO X-RAY WAS PERFORMED TO LOCATE THE COMPONENT OR CONFIRM THAT ALL PIECES WERE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25045720 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC G-TUBE PLACEMENT, THE INTERNAL SEAL DISLODGED DURING CASE AND WAS RETRIEVED WITH LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205863 ↗
• MalfunctionJan 28, 2026Difficult to Insert; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC EXPLORATION BEING DONE ON A PATIENT WITH NON-PALPABLE TESTES WHERE ONE TESTICLE WAS LOCATED IN THE ABDOMEN, THE SURGEON REQUESTED TO APPLY AN ENDOSCOPIC CLIP TO A PART OF THE TISSUE. THE SURGEON WAS INSERTING THE CLIP APPLIER THROUGH THE LAPAROSCOPIC PORT ON THE PATIENT'S LEFT ABDOMEN BUT WAS MEETING RESISTANCE. THE CLIP DID COME THROUGH UNDER LAP VISUALIZATION INTO THE ABDOMEN, BUT A PIECE OF UNKNOWN MATERIAL WAS SEEN COMING THROUGH THE PORT AS WELL. THE SMALL PIECE RELEASED INTO THE CAVITY BUT REMAINED UNDER CONSTANT VISUALIZATION AND WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE FIELD. THE MATERIAL APPEARS TO BE A PIECE OF THE SILICONE VALVE THAT WOULD BE INSIDE THE LAPAROSCOPIC PORT. THE PORT WAS REMOVED AND WAS REPLACED RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205647 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC ANORECTAL MALFORMATION (ARM) WITH A SMALL OPEN INCISION AT THE ANUS, WHEN THE REDUCER WAS PLACED IN SUPERIOR POSITION OF THE PORT IN THE ABDOMEN, THE PEDIATRIC SIZED INSTRUMENT WAS PLACED THROUGH THE TROCAR. DURING NORMAL USE, THE SMALL INTERNAL SILICONE O-RING SEAL WAS DAMAGED AND DETACHED. THE DOCTOR NOTED THAT THE SEAL WILL BE LOOKED FOR AT THE END OF CASE, BUT THE SMALL SEAL WAS NEVER FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199128 ↗
• MalfunctionDec 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEAL DISENGAGED AND ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897560 ↗
• MalfunctionDec 25, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY OF LAPAROSCOPIC GASTROPEXY, THE JAWS OF THE TWO CLIP APPLIERS WOULD NOT OPEN ALL THE WAY AND WOULD NOT FIRE. ADDITIONALLY, THE CANNULA BROKE FOR BOTH THE PORTS. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892199 ↗
• MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SEAL OF A 5-MILLIMETER (MM) PORT CAME OUT, FELL INTO THE PATIENT AND ALL PIECES WERE LOCATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891422 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, A PIECE OF THE INNER CANNULA BROKE OFF WHEN AN INSTRUMENT WAS REMOVED FROM THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363466 ↗
• MalfunctionAug 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AS THE SURGEON WAS FINISHING UP, THE RESIDENT WAS ABOUT TO REMOVE THE L HOOK FROM THE TROCAR AND SPOTTED A FOREIGN PIECE ON THE END OF THE L HOOK. WHEN THE USER PULLED OUT THE L HOOK, THE PIECE CAME OFF AND IT WAS DISCOVERED IT WAS A PART OF ONE OF THE PED TROCARS USED IN THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901101 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE; THE PLASTIC INTERNAL VALVE DETACHED FROM THE 5MM DILATOR AND CANNULA AND FELL INTO THE PATIENT. THE PLASTIC INTERNAL VALVE WAS FOUND AND REMOVED DURING THE SURGERY, AND BOTH THE PIECE AND THE DILATOR WERE SAVED AND GIVEN TO MANAGEMENT AFTER THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679626 ↗
• MalfunctionJun 20, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE INITIAL ACCESS STEP OF A LAPAROSCOPIC HERNIA REPAIR, THE THREE RADIALLY EXPANDABLE SLEEVES BECAME BENT AND UNUSABLE DURING THREE SEPARATE INSERTION ATTEMPTS, AND THE CANNULA BROKE. THE PHYSICIAN USED A TOTAL OF FOUR RADIALLY EXPANDABLE SLEEVES TO GAIN ACCESS, SUCCESSFULLY INSERTING THE FOURTH SLEEVE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303308 ↗
• MalfunctionJun 20, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE INITIAL ACCESS STEP OF A LAPAROSCOPIC HERNIA REPAIR, THE THREE RADIALLY EXPANDABLE SLEEVES BECAME BENT AND UNUSABLE DURING THREE SEPARATE INSERTION ATTEMPTS, AND THE CANNULA BROKE. THE PHYSICIAN USED A TOTAL OF FOUR RADIALLY EXPANDABLE SLEEVES TO GAIN ACCESS, SUCCESSFULLY INSERTING THE FOURTH SLEEVE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303292 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE WHILE INSERTING AN INSTRUMENT THROUGH THE PORT, A PIECE FROM THE PORT FELL INTO THE CAVITY OF THE PATIENT. THE PIECE FROM THE PORT WAS RECOGNIZED AND RETRIEVED IMMEDIATELY FROM THE PATIENT AND NO OTHER PIECES WERE FOUND TO BE MISSING OR INSIDE THE PATIENT. NO X-RAY WAS PERFORMED TO LOCATE THE COMPONENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758123 ↗
• InjuryJan 3, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, A LAPAROSCOPIC APPROACH WAS CONVERTED TO OPEN SURGERY DUE TO A PROBLEM WITH THE FOUR TROCAR DEVICES, SPECIFICALLY THE FRAYING OF THE TROCARS' SHIRT. THIS CONVERSION RESULTED IN A LARGER THAN EXPECTED INCISION, LEADING TO PERMANENT TISSUE DAMAGE AND A 10 CENTIMETER (CM) SCAR. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE, INCREASING THE RISK OF INFECTION DUE TO PROLONGED ANESTHESIA AND OPEN SURGERY. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH (2.54 CM). UNANTICIPATED TISSUE LOSS WAS NOTED.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 21072071 ↗
• InjuryOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, EIGHT MONTHS POSTOPERATIVE OF A PROCEDURE, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A PLANNED SURGERY. A SMALL PLASTIC RING WAS THEN DISCOVERED INSIDE THE PATIENT'S ABDOMEN. A PIECE OF A PORT USED LIKELY DISLODGED AND REMAINED IN THE PATIENT AT THAT TIME DURING THE PREVIOUS SURGERY. THE SMALL PLASTIC RING WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20561677 ↗

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