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Savary-Gilliard G22139Recalls & reported problems

Cook Incorporated · Savary-Gilliard Wire Guide · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002221390), received between Sep 26, 2018 and Nov 5, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

  • Deformation Due to Compressive Stress1
  • Material Twisted/Bent1

Patient problems

  • No Consequences Or Impact To Patient1
  • Perforation1

Recent adverse event reports

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

  • MalfunctionNov 5, 2018Material Twisted/Bent; Material Twisted/Bent

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. ONE OF THE GUIDE WIRES BENT WHEN THE PHYSICIAN PUT IT IN THE ENDOSCOPE. HE SAID HE HAS NEVER BENT A WIRE GUIDE IN HIS LAST, HOWEVER MANY, YEARS AS A PHYSICIAN. HE IS REQUESTING THAT YOU REPLACE IT AS HE FEELS IT HAD A DEFECT OR THIS WOULD NOT HAVE OCCURRED AS THIS IS ONLY THE SECOND WEEK USING THE WIRE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8037750 ↗
  • InjurySep 26, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK SAVARY-GILLIARD WIRE GUIDE. THERE WAS A BLEED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 09 SEPTEMBER 2018: THE PATIENT WAS SCHEDULED AND ARRIVED FOR EGD UNDER MONITORED ANESTHESIA CARE AS AN OUTPATIENT PROCEDURE. THE PROCEDURE WAS PERFORMED WITHOUT REPORT OF CLINICAL DIFFICULTY. THE PATIENT PROGRESSED TO POST OPERATION PROGRESSIVE RECOVERY WITH STABLE VITAL SIGNS AND GIVEN COLA TO DRINK WHEN AWAKE. THE PATIENT THEN BEGAN TO COMPLAIN OF PAIN IN THE RIGHT ABDOMEN RADIATING TO THE REAR. THE BOWEL SOUNDS WERE QUIET, AND THE ABDOMEN WAS TIGHT. THE PHYSICIAN WAS NOTIFIED AND SAW THE PATIENT. AN ACUTE ABDOMINAL SERIES WAS COMPLETED IN X RAY. THE PATIENT THEN COMPLAINED OF NAUSEA. THE PHYSICIAN THEN INFORMED THE PATIENT OF A PERFORATION. THE ACUTE ABNORMAL SERIES SHOWED SIGNIFICANT PNEUMOPERITONEUM. A SURGEON WAS CONSULTED, AND THE PATIENT WAS MEDICATED FOR PAIN AND NAUSEA AND ANTIBIOTICS WERE STARTED. THE PATIENT WAS THEN TRANSFERRED VIA AIR HELICOPTER TO ANOTHER HOSPITAL. THE PATIENT'S VITAL SIGNS WERE STABLE WITH INCREASE IN BLOOD PRESSURE WITH PAIN. THE DEVICE WAS EVALUATED AND DETERMINED TO HAV

    Patient problems: Perforation

    MAUDE report 7909776 ↗

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Sources and updates

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