CONMED 130188Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405059923), received between May 8, 2026 and May 8, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Activation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033003); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Activation Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, 130188, ELECTROSURGICAL SUCTION COAGULATOR, 10FR, WAS USED DURING A TONSILLECTOMY & ADENOIDECTOMY PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿2YR OLD PATIENT SUSTAINED BURNS TO THE INSIDE AND OUTSIDE CORNERS OF HER MOUTH BILATERALLY, DURING TONSILLECTOMY PROCEDURE. PATIENT SUSTAINED PARTIAL TO FULL-THICKNESS BURNS TO THE INSIDE AND OUTSIDE OF HER MOUTH BILATERALLY DURING A TONSILLECTOMY. THE PHYSICIAN IDENTIFIED THE INJURY IMMEDIATELY FOLLOWING THE PROCEDURE AND APPLIED SALINE TO THE AFFECTED AREAS. AT THAT TIME, I LEFT THE ROOM TO NOTIFY THE CHARGE RN AND TO REQUEST ASSESSMENT FROM PLASTICS, WHO WAS ALSO PRESENT IN THE OR AREA TODAY. PLASTICS CAME TO THE ROOM, COMPLETED AN ASSESSMENT, TOOK PHOTOGRAPHS, AND RECOMMENDED ADMISSION OF THE PATIENT. DURING THIS SAME PERIOD CNE AND BIOMED ENGINEER ATTENDED THE ROOM TO ASSESS THE CAUTERY EQUIPMENT. THE MONOPOLAR UNIT, SUCTION MONOPOLAR, CAUTERY TIP, CAUTERY PAD, AND ASSOCIATED PACKAGING WERE RETAINED FOR EVALUATION. I WOULD LIKE TO NOTE THAT PRIOR TO THE START OF THE CASE, THE PHYSICIAN HAD INDICATED THAT THE CAUTERY WAS NOT ACTIVATING. I IMMEDIATELY CHECKED ALL CONNECTIONS, AND BOTH MYSELF AND T

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25122262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033003. One submission often covers many models, so check the product and lot details in each record.

• Z-0474-2023 · Nov 18, 2022 · Terminated
  Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187