TeslatomeRecalls & reported problems across all models

We found 2 models of Teslatome by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Teslatome recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported Teslatome problems

Teslatome models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Teslatome G60784

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall2 reports
• Teslatome G60785

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Recent Teslatome adverse event reports

The 2 most recent reports across all models, 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 ↗

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