n.a. 27040G-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551393246), received between Oct 31, 2018 and Jan 12, 2022 — classified as 1 injury, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: "COLONIC PERFORATION POSTERIOR SIDE OF UTERUS DISCOVERED 24 HOURS LATER." CURRENTLY NO FURTHER INFORMATION REGARDING HEALTH EFFECTS AVAILABLE. A 26040SL RESECTOSCOPE SHEATH AND AN INNER SHEATH 27040XA WERE INVOLVED. NO INDICATION OF MALFUNCTION OF THE PRODUCT. (MANUFACTURER'S INTERNAL COMPLAINT #(B)(4)).

  Patient problems: Bowel Perforation; Internal Organ Perforation; Uterine Perforation

  MAUDE report 13235990 ↗
• MalfunctionOct 31, 2018Break; Detachment of Device or Device Component

  ALLEGEDLY, DURING A PROCEDURE, THE LOOP OF THE ELECTRODE BROKE OFF INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE IT; THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026803 ↗