NA 8667961Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207019245), received between Aug 16, 2018 and Aug 16, 2018 — classified as 1 injury.

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

• InjuryAug 16, 2018Break; Break

  ON 8/15/2018 RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREINAFTER REFERRED TO AS RWMIC, WAS MADE AWARE OF AN EVENT FROM RICHARD WOLF (B)(4) HEREINAFTER REFERRED TO AS (B)(4) OF AN INCIDENT THAT OCCURRED AT A HOSPITAL IN (B)(6). (B)(4) WAS NOTIFIED BY (B)(6) AUTHORITIES ON A DATE YET TO BE DETERMINED THAT A SIGNIFICANT INJURY OCCURRED DURING A PROCEDURE IN THE HOSPITAL INVOLVING A (B)(6) MALE PATIENT. (B)(4) ATTEMPTED TO CONTACT THE USER FACILITY TO OBTAIN INFORMATION ON THE DEVICE, PRODUCT CODE, LOT NUMBER BUT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THAT TIME. AN OPTICAL URETHROTOMY WAS PERFORMED ON THE PATIENT ON (B)(6) 2018 AND AT THE VERY BEGINNING OF THE PROCEDURE, JUST AFTER THE URETHROTOMY HAD BEEN PERFORMED, IT WAS NOTED THAT THE BLADE HAD BECOME DISLODGED FROM THE END OF THE INSTRUMENT AND HAD BECOME EMBEDDED IN THE PERI-URETHRAL TISSUES. THE USER MADE REPEATED ATTEMPTS TO FIND AND REMOVE THIS BLADE BUT WAS UNABLE TO DO SO, DESPITE USING FLUOROSCOPIC SCREENING IN THE OPERATING THEATRE. VARIOUS DIFFERENT SCOPES WERE USED AS WELL AS DIFFERENT TYPES OF GRASPERS. THE PATIENT SUFFERED A VERY SIGNIFICANT INJURY AS A RESULT OF THE EQUIPMENT MALFUNCTION AND THE ATTEMPTS MAD

  Patient problems: Device Embedded In Tissue or Plaque; Necrosis; Swelling

  MAUDE report 7791287 ↗