n.a. 27050G-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551394540), received between Aug 24, 2017 and Oct 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP BROKE OFF DURING THE CASE AND NEEDED TO BE RETRIEVED VIA GRASPERS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350624 ↗
• MalfunctionSep 24, 2022Energy Output Problem; Material Separation; Energy Output Problem; Material Separation

  THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4) WHICH REPORTS ALL INCIDENTS IN ONE CASE. THREE RELATED COMPLAINTS TO THIS EVENT (B)(4), (B)(4) AND (B)(4). IN A CASE ON (B)(6) 2022 WITH DR. (B)(6), PER THE STAFF IN THE ROOM, 4 LOOPS OUT OF THE SAME BOX BROKE RIGHT IN THE MIDDLE OF THE LOOP EVERY TIME (THIS WAS TRUE FOR ALL OF THEM). NO HARM REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477677 ↗
• MalfunctionNov 19, 2020Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A TURP THE DOCTOR NOTICED AT THE END OF THE PROCEDURE THAT THE LOOP BROKE IN HALF AND PER THE SURGEON NOTHING FELL INSIDE THE PATIENT, AND WITH NO ILL EFFECTS TO THE PATIENT. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10872506 ↗
• MalfunctionJun 10, 2020Material Separation; Material Separation

  AS PER AN AER FROM (B)(6) RECEIVED BY THE FACTORY IN (B)(4): BROKE INSIDE THE UTERUS. EXTENSION OF THE INTERVENTION FOR RECOVERY OF THE BROKEN PART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140857 ↗
• MalfunctionNov 6, 2019Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A TURP THE DOCTOR NOTICED A PIECE OF THE WIRE FROM THE LOOP ARCHED AND FELL OFF IN THE PATIENT. THE DOCTOR REMOVED THE BROKEN PIECE BY "FLUSHING THE FRAGMENT OUT" PER THE NURSE, WITH NO ILL EFFECTS TO THE PATIENT. THE ELECTRODE WAS REPLACED AND THE PROCEDURE COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285317 ↗
• MalfunctionOct 12, 2017Material Separation; Material Separation

  ALLEGEDLY, THE ELECTRODE BROKE DURING THE PROCEDURE AND FELL INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE BROKEN PIECE AND HOSPITAL REPORTED THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6946957 ↗
• MalfunctionAug 30, 2017Material Separation; Material Separation

  ALLEGEDLY, THE DOCTOR WAS PERFORMING A TURP WHEN THE LOOP BROKE OFF INTO THE PATIENT. THE DOCTOR IMMEDIATELY RETRIEVED, REPLACED INSTRUMENT AND COMPLETED PROCEDURE. THE HOSPITAL REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6831508 ↗
• MalfunctionAug 30, 2017Material Separation; Material Separation

  ALLEGEDLY, THE DOCTOR WAS PERFORMING A TURP WHEN THE LOOP BROKE OFF INTO THE PATIENT. THE DOCTOR IMMEDIATELY RETRIEVED, REPLACED INSTRUMENT AND COMPLETED PROCEDURE. THE HOSPITAL REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6831504 ↗
• MalfunctionAug 24, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING A CYSTOSCOPY PROCEDURE THE DOCTOR NOTED THAT A PIECE OF THE LOOP BROKE DURING THE PROCEDURE AND FELL INTO THE PATIENT'S BLADDER. THE INSTRUMENT WAS REPLACED AND THE PIECE WAS IMMEDIATELY REMOVED. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND THE HOSPITAL REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819103 ↗