Teslatome G60784Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002607842), received between Nov 18, 2025 and Nov 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Dec 18, 2025Open, Classified

   Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

   Z-1362-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 21, 2025Structural Problem; Structural Problem

  DURING AN ERCP, THE PHYSICIAN USED A COOK TESLATOME BIPOLAR SPHINCTEROTOME. THEY WERE CANNULATING WITH A WIRE UP THE PANCREATIC DUCT. THEY STRIPPED THE SPHINCTEROTOME BACK AND RELOADED WITH ANOTHER WIRE TO CANNULATE THE BILE DUCT. THE BILE DUCT WAS CANNULATED, AND THEY WENT TO DO THE SPHINCTEROTOMY. THEY STARTED THE SPHINCTEROTOMY. THEY MADE A LITTLE CUT. THEY REPOSITIONED AND WENT BACK TO START EXTENDING THE CUT. WHEN THEY STARTED TO CUT, THEY CUT THE GUIDE WIRE IN HALF. A PIECE OF THE GUIDE WIRE SPLIT THE TIP OF THE TOME AND CUT IT BACK TO THE GROUNDING PAD INK ON THE TOME. THEY REMOVED THIS DEVICE AND THE PIECE OF GUIDE WIRE THAT WAS UP IN THE BILE DUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MANUFACTURERS SPHINCTEROTOME. 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 FURTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618355 ↗
• MalfunctionNov 18, 2025Structural Problem; Structural Problem

  DURING AN ERCP, THE PHYSICIAN USED A COOK TESLATOME BIPOLAR SPHINCTEROTOME. THEY CANNULATE WITH AN OLYMPUS .025 VISIGLIDE WIRE GUIDE. THERE WERE THREE ATTEMPTED CUTS WITH THE TESLATOME. ON ALL 3 CUTS, PATIENT WAS NOTED TO ¿JOLT¿, AND HEART RATED ELEVATED. THE PHYSICIAN SWITCHED TO A ANOTHER MANUFACTURER¿S MONOPOLAR TOME TO FINISH THE CUT. THIS WAS COMPLETED WITH NO ADVERSE SIDE EFFECTS. FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT: WHAT WAS NOTED WAS A PHYSICAL JOLT OF THE PATIENT'S BODY EXTERNALLY. NOTHING INTERNALLY VIA THE ENDOSCOPE. THE AMPULLA WAS BEING WATCHED WHEN THEY WERE DOING THE CUTTING AND A TISSUE RESPONSE WAS NOTED. THE PHYSICIAN AND THE TECH NOTICED A ¿FULL BODY RESPONSE¿. THE ANESTHESIOLOGIST CONFIRMED THE PATIENT¿S HEART RATE ELEVATED IN THOSE INSTANCES. THE USERS STOPPED AND WE CONFIRMED THAT EVERYTHING WAS PLUGGED IN CORRECTLY. AN ADDITIONAL CUT WAS PERFORMED WITH THE SAME REACTION. IT WAS NOTED THERE WAS A STONE AT THE DOORWAY OF THE AMPULLA. WHEN THEY WERE CUTTING, THEY WERE CUTTING THROUGH A STONE. THERE WAS NO VISIBLE ARCING AND NO IMPLANTS IN THE PATIENT OTHER THAN HEMOCLIPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PAT

  Patient problems: Cramp(s) /Muscle Spasm(s); Inappropriate Device Stimulation of Tissue

  MAUDE report 23586451 ↗