NA 8393705Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207016183), received between May 15, 2017 and May 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2017Material Fragmentation; Material Fragmentation

  FACILITY CONTACTED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (B)(4) AND RELAYED THAT DURING A PROCEDURE A PIECE OF WIRE ON THE DEVICE IN QUESTION FELL OFF INTO PATIENT. AN X-RAY WAS PERFORMED IN ORDER TO LOCATE AND RETRIEVE FOREIGN OBJECT. ONCE RETRIEVED A BACK UP DEVICE WAS USED TO COMPLETE PROCEDURE. NO INJURY TO PATIENT REPORTED. THE DELAY IN LOCATING AND RETRIEVING FOREIGN OBJECT MAY HAVE PLACED PATIENT AT RISK. MANUFACTURE DATE - OCT2009 (7 1/2 YEARS OLD). NO SIMILAR ISSUES REPORT ON THIS DEVICE IN THE LAST THREE YEARS. REQUEST FOR ADDITIONAL/MISSING INFORMATION HAS BEEN SENT TO USER FACILITY, NO RESPONSE AS OF 15MAY2017. DEVICE RECEIVED AT (B)(4) (IMPORTER) ON 21APR2017. DEVICE TO BE SENT TO RICHARD WOLF (B)(4) (MANUFACTURER) ON 17MAY2017 FOR INVESTIGATION. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(4) RECEIVES ANY ADDITIONAL INFORMATION, (B)(4) WILL PROVIDE (B)(4) (MANUFACTURER) WITH FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6566711 ↗