VersaStep Plus VS101512PRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521082854), received between Nov 28, 2018 and Apr 19, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 19146895 ↗
• MalfunctionMar 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A SMALL PLASTIC PIECE OF THE DEVICE WAS BROKEN WHILE IN USE AND COULD NOT BE LOCATED. NOTHING FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 8408259 ↗
• MalfunctionJan 30, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, HALF OF A PEA SIZED PLASTIC WAS BROKE OFF AT THE DISTAL END OF THE DEVICE. IT WAS REPORTED BROKEN PIECE WAS FOUND BARELY ATTACHED TO THE OUTSIDE OF THE DEVICE AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289169 ↗
• MalfunctionJan 2, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, WHILE REMOVING THE CANNULA FROM THE ABDOMINAL WALL, A PIECE OF THE CANNULA CHIPPED OFF AT THE DISTAL END. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8208306 ↗
• MalfunctionDec 13, 2018Break; Detachment of Device or Device Component

  COVIDIEN BRAND, 12MM TROCAR FOR DAVINCI CAMERA HAD A HALF OF A PEA SIZED PLASTIC BROKE OFF AT THE DISTAL END OF THE TROCAR. BROKEN PIECE WAS FOUND BARELY ATTACHED TO THE OUTSIDE OF THE TROCAR AFTER USE. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: UTERINE FIBROIDS.

  Patient problems: No Information

  MAUDE report 8164943 ↗
• MalfunctionNov 28, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC HYSTERECTOMY PROCEDURE, THE SURGEON MISALIGNED THE TROCAR AND PIERCED THE SLEEVE ON THE SIDE. A PIECE OF THE CANNULA BROKE OFF AND FELL INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED BY A GRASPER. THEY REPLACED THE SLEEVE TO RE-ENTER THE ABDOMEN. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8113924 ↗