Mini Step MS100705Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 20884521082707), received between Jun 19, 2017 and Apr 30, 2026 — classified as 7 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (62 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 91 reports, 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 ↗
• MalfunctionMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT ORCHIDOPEXY UNILATERAL PROCEDURE, THE TIP OF THE TROCAR BROKE OFF. THERE WAS A STAPLE ON THE BROKEN TIP BECAUSE THE SURGEON HAD TO USE THE STAPLER TO TAKE THE TIP OUT OF THE ABDOMEN OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946234 ↗
• MalfunctionOct 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROSTOMY TUBE, WHEN INFLATING THE TROCAR AND USING ELBOW ITEMS, AN ORANGE PIECE BROKE OFF FROM THE TROCAR AND FELL INTO THE PATIENT'S CAVITY. THE ITEM WAS RETRIEVED BY USING A GRASPER. A NEW TROCAR WAS OPENED TORESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026608 ↗
• MalfunctionSep 25, 2023Detachment 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 LAPAROSCOPIC GASTROSTOMY TUBE PLACEMENT, WHEN DOING A NORMAL INSTRUMENT EXCHANGE THROUGH THE PORT, THE SEAL OF THE TROCAR WAS DAMAGED AND A SMALL PIECE FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED VIA A LAPAROSCOPIC HAND INSTRUMENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810247 ↗
• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN CLIPPING THE DUCT, THE SEAL BECAME SEPARATED FROM THE TROCAR. A NEW TROCAR WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079505 ↗
• MalfunctionApr 17, 2023Detachment 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 LAPAROSCOPIC PROCEDURE, THE SEAL WAS DAMAGED. WHEN INSERTING THE CAMERA INTO A DISPOSABLE TROCAR, A SMALL RUBBER PIECE CAME OFF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16755676 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A SMALL PIECE OF THE TROCAR WAS FOUND AFTER BEING REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 16067184 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A DIAGNOSTIC LAPAROSCOPY, A SMALL PIECE OF THE TROCAR ORANGE ADAPTOR WAS FOUND ON THE GROIN AFTER IT WAS REMOVED FROM THE PATIENT. AFTER THE PIECE WAS FOUND, THE TROCAR WAS INSPECTED FOR COMPLETENESS AND VERIFIED THAT IT WAS.

  Patient problems: Insufficient Information

  MAUDE report 16067102 ↗
• MalfunctionDec 6, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, AT THE END OF THE PROCEDURE, THE CANNULA BROKE AND IT WAS NOTICED THAT A SMALL ORANGE PIECE OF THE DEVICE FELL INTO THE PATIENTS GROIN AND WAS REMOVED WITH A GRASPER. THE FOREIGN BODY WAS REMOVED BEFORE CLOSING THE PATIENTS CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928621 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC APPENDECTOMY, THE TROCAR DILATOR PIECE OF THE DEVICE DETACHED FROM O UTSIDE THE ABDOMEN. THE PIECE HAD TO BE RETRIEVED BY THE SURGEON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716876 ↗
• InjuryOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, A FIVE MILLIMETER CLIP APPLIER WAS INSERTED IN THE PORT. THE APPLIER CAUGHT ON THE SILICONE RING WHICH BECAME DISLODGED FROM THE DEVICE AND FELL INTO THE PATIENT'S ABDOMEN. ANOTHER DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. THE SURGEON WAS ONLY ABLE TO LOCATE AND REMOVE ONE RING.

  Patient problems: Foreign Body In Patient

  MAUDE report 15638438 ↗