OPTIMIZER 000478Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653405053422), received between May 31, 2016 and Sep 11, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A COLONOSCOPY THE CONSULTANT FED 000478 SNARE DOWN THE SCOPE AND THE SNARE HEAD DETACHED WHEN PLACED OVER THE POLYP. BIOPSY FORCEPS WERE USED TO RETRIEVE THE DETACHED SNARE HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER CONMED SNARE AND A SURGICAL DELAY WAS NOT REPORTED. NO PATIENT INJURY REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6855968 ↗
• MalfunctionDec 9, 2016Detachment Of Device Component

  AS REPORTED BY THE USER FACILITY, DURING A COLONOSCOPY POLYPECTOMY ON (B)(6) 2016, "THE POLYPECTOMY SNARE WIRE DETACHED FROM THE DEVICE AND FELL OFF INTO THE LUMEN OF THE BOWEL." FOLLOW UP INFORMATION WITH THE FACILITY REVEALED THAT BOTH THE POLYP AND SNARE WIRE WERE RETRIEVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A MINIMAL DELAY OF A FEW MINUTES AND NO PATIENT INJURY. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6159790 ↗
• MalfunctionSep 15, 2016Detachment Of Device Component

  THE END-USER FACILITY REPORTED THAT DURING USE OF THE OPTIMIZER POLYPECTOMY SNARE IN A COLONOSCOPY PROCEDURE, THE SNARE LOOP WAS DETACHED IN THE PATIENT AND HAD TO BE RETRIEVED WITH FORCEPS. THE CASE WENT ON WITH NO FURTHER COMPLICATIONS OR PROBLEMS REPORTED AND THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO SURGICAL DELAY OR PATIENT INJURY. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5952941 ↗
• MalfunctionMay 31, 2016Break

  PER END-USER FACILITY, THE OPTIMIZER POLYPECTOMY SNARES BROKE OFF IN THE PATIENT'S COLON AND HAD TO BE RETRIEVED WITH FORCEPS. THIS OCCURRED THREE TIMES IN THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A FOURTH SNARE WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EVENT HAS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5688481 ↗