Savary Gilliard G57281Recalls & reported problems
Cook Incorporated · Savary Gilliard Wire Guide · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002572812), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
Device problems
- Improper or Incorrect Procedure or Method1
- Material Twisted/Bent1
Patient problems
- Laceration(s) of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2020Improper or Incorrect Procedure or Method; Material Twisted/Bent; Improper or Incorrect Procedure or Method; Material Twisted/Bent
DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. WHILE PLACING THE ESOPHAGEAL STENT, THE WIRE WAS IN PLACE. WHEN THE PHYSICIAN WENT TO PLACE THE STENT OVER THE WIRE, THERE WAS VISIBLE RESISTANCE. PHYSICIAN WAS HAVING DIFFICULTY PUSHING THE STENT OVER THE WIRE IN THE PATIENTS MOUTH. WHEN THE PHYSICIAN PULLED THE STENT OUT OF THE WIRE, THE WIRE WAS BENT IN THREE (3) PLACES. WHEN THE WIRE AND STENT WERE PULLED OUT, THE ENDOSCOPE WAS PUT BACK DOWN AND THE PHYSICIAN COULD SEE BLEEDING THAT WAS NOT NOTICED PRIOR. LATER, THE PHYSICIAN NOTICED A TEAR IN THE THROAT AFTER ATTEMPTING TO PLACE THE STENT. PHYSICIAN STATED FORCING THE STENT WAS THE REASON FOR THE TEAR. IT IS CURRENTLY UNKNOWN IF THE BLEEDING [INITIALLY SEEN AFTER THE WIRE GUIDE WAS FOUND BENT] IS RELATED TO THE TEAR. ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER ON (B)(6) 2020. THE USER FACILITY IS UNABLE TO PINPOINT WHAT CONTRIBUTED TO THE TEAR. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED SUTURES FOR A TEAR IN THE THROAT EXPERIENCING BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRE
Patient problems: Laceration(s) of Esophagus
MAUDE report 9656079 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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