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VersaStep VS101500Recalls & reported problems

Covidien LP · Long Radially Expandable Sleeve · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521084152), received between Nov 28, 2018 and Nov 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Device problems

  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 8113926 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.