NA 8384423Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207015278), received between Jun 23, 2017 and Jun 10, 2021 — classified as 3 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE SEE MANUFACTURERS NARRATIVE FOR PRODUCT EVALUATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11979362 ↗
• MalfunctionJan 26, 2021Break; Break

  ON DECEMBER 23, 2020 RICCHARD WOLF GMBH WAS INFORMED BY RW (B)(6) ABOUT A PRODUCT PROBLEM: AT THE END OF THE LAPAROSCOPY HOOK BROKE AT THE BELLY DURING THE PROCEDURE. THE HOOK WAS FOUND IN THE CAVITY AND REMOVED. WITHOUT CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229287 ↗
• MalfunctionJun 23, 2017Material Fragmentation; Material Fragmentation

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY FACILITY THAT DURING A PROCEDURE THE TIP OF THE DEVICE IN QUESTION WENT MISSING AFTER SURGEON PULLED THE DEVICE FROM THE TROCAR. A SEARCH WAS PERFORMED WITH A FLUOROSCOPY IT COULD NOT BE CONFIRMED TIP WAS LEFT IN PATIENT, TIP WAS NEVER FOUND. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6664057 ↗