RESECTION MASTER 86592351Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207028117), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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.

• MalfunctionMar 23, 2018Thermal Decomposition of Device; Material Discolored; Thermal Decomposition of Device; Material Discolored

  RICHARD WOLF (B)(4) (RW(B)(4)) WAS NOTIFIED BY USER FACILITY THAT DURING A PROCEDURE THE TIP OF THE SHEATH BROKE INTO PIECES AND FELL INTO THE PATIENT. PIECES WERE RECOVERED FROM PATIENT. FACILITY ALSO REPORTED BURN MARKS ON THE WORKING ELEMENT AND DAMAGED ELECTRODE. AT THIS TIME, THE WORKING ELEMENT AND SHEATH ARE SUSPECT DEVICES AND A REPORT WILL BE SUBMITTED FOR EACH DEVICE. WORKING ELEMENT (ID #(B)(6)) (MDR 9611102-2018-00007); OUTER SHEATH (ID #(B)(6)) (MDR 9611102-2018-00006). WORKING ELEMENT MANUFACTURED ON 17OCT2017 WITH A BATCH SIZE OF 5 UNITS. SHEATH WAS PURCHASED BY FACILITY ON (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367700 ↗