Instinct G57302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002573021), received between Oct 10, 2022 and Dec 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS REPORTED THAT DURING AN ERCP WE [PHYSICIAN AND TEAM] HAD AN ISSUE WITH THE GUIDEWIRE WHEN EXCHANGING THE SPHINCTEROTOME AND WE HAD TO CUT THE GUIDEWIRE TO GET THE SPHINCTEROTOME OFF. IT APPEARS THE GUIDEWIRE COATING PEALED OFF. IMAGES OF THE DEVICE SHOWING WIRE GUIDE COATING DAMAGE WERE PROVIDED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20896273 ↗
• MalfunctionJan 16, 2023Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS REPORTED THAT THE SPHINCTEROTOME WAS RETRIEVED AND THE PHYSICIAN TRIED TO REINSERT INTO THE WIRE LOCK. THE DISLOCATED CUTTING WIRE REFUSED TO BE PUSHED THROUGH THE WIRE LOCK. AFTER CHECKING THE TIP IT WAS REALIZED THE A PART OF THE CUTTING WIRE WAS DISLOCATED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16174282 ↗
• MalfunctionOct 10, 2022Peeled/Delaminated; Sharp Edges; Peeled/Delaminated; Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT 2 WIRE GUIDE. IT WAS REPORTED THAT ON OPENING DEVICE, NO ABNORMALITIES WERE EVIDENT. THE FORMING WIRE WAS REMOVED WITH NO ISSUES. THE TOME WAS FLUSHED AGAIN WITH SALINE BUT THE WIRE WAS COMPLETELY STUCK. THE TOME WAS REMOVED AND UPON INSPECTION IT WAS NOTED THAT THE TOME TIP [WIRE GUIDE TIP] WAS NOT INTACT [COATING DAMAGE] AND THAT THE WIRE WAS GETTING STUCK AT THE PROXIMAL PART OF THE CUTTING WIRE PORTION OF THE TOME - IT APPEARS THE CATHETER IS SMALLER IN THAT SECTION THAN THE REST OF THE TOME [MANUFACTURED TO BE TAPERED]. THE ITEM WAS REMOVED FROM THE SCOPE AND DISCARDED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH COMPETITOR PRODUCT. PER OUR EVALUATION OF THE RETURNED DEVICE ON 10/28/2022: THERE IS NO COATING DAMAGE OF THE WIRE GUIDE. INSTEAD, THERE IS DAMAGE AT THE DISTAL TIP OF THE SPHINCTEROTOME CATHETER. [SUBJECT OF REPORT] 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 ADVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572981 ↗