None 470015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874112199), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended System Motion” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 21, 2021Terminated

   Incorrect expiration date on its package labeling (shipper box and inner carton label).

   Z-0275-2022 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 29, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT EXHIBITED NON-INTUITIVE MOVEMENT. THE INSTRUMENT JAW ALLEGEDLY "MOVED IN THE WRONG DIRECTION." TROUBLESHOOTING WAS PERFORMED BY REMOVING AND REINSTALLING THE SAME INSTRUMENT BACK INTO THE ARM AND THIS RESOLVED THE ISSUE. FOLLOWING THIS, THE INSTRUMENT MOVEMENT WAS CONFIRMED AND OPERATED WITHOUT ERROR. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. THE USER SUSPECTS A FAULTY DRAPE. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14863899 ↗