Savary Gilliard G57280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002572805), received between Jan 29, 2020 and Jan 7, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Twisted/Bent

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. IT WAS REPORTED [THAT] WHEN USER OPENED THE PACKAGE, THEY NOTICED THAT THE TIP OF THE WIRE WAS SIGNIFICANTLY KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993951 ↗
• InjuryJun 26, 2020Material Twisted/Bent; Material Twisted/Bent

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. THE DEVICE WAS ADVANCED AND THE DILATION WAS PERFORMED. WHEN GUIDE WIRE WAS REMOVED IT WAS NOTED THAT THE WIRE WAS BROKEN AT THE BASE OF THE SPRING COIL. THE PHYSICIAN THEN NOTED THAT DUE TO THE BROKEN WIRE THE ESOPHAGUS WAS PERFORATED. USING A COMPETITORS CLIPPING DEVICE EIGHT CLIPS WERE DEPLOYED TO CLOSE THE PERFORATION SUCCESSFULLY. THE PATIENT WAS TRANSPORTED TO IN-HOUSE TO BE MONITORED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED THE USE OF CLIPS DUE TO THIS OCCURRENCE. THE PATIENT WAS TRANSPORTED TO IN-HOUSE TO BE MONITORED.

  Patient problems: Perforation of Esophagus

  MAUDE report 10201180 ↗
• MalfunctionJan 29, 2020Material Twisted/Bent; Material Twisted/Bent

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. THE PHYSICIAN WAS DILATING A STRICTURE AND NOTED THE WIRE WAS "NOT GOING DOWN", SO HE PULLED IT OUT AND FOUND THAT THE WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH A REUSABLE WIRE GUIDE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9641649 ↗