NA 130187Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30653405059930), received between May 17, 2018 and Jun 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 18, 2022Terminated

   Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

   Z-0474-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE 130187, ELECTROSURGICAL SUCTION COAGULATOR 10F, DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING AN ADENOIDECTOMY PROCEDURE WHEN IT WAS REPORTED ¿SURGEON REPORTS A SPARK AND A BURN THAT CAME "THROUGH THE INSULATED PART OF THE SUCTION BOVIE.¿. IT WAS ALSO REPORTED ¿PATIENT HAD A 1X2MM SUPERFICIAL BURN TO RIGHT UPPER LIP.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22178366 ↗
• MalfunctionJan 25, 2024Material Fragmentation; Material Fragmentation

  THIS COMPLAINT ARISES FROM THE RECEIPT OF MEDWATCH UF/IMPORTER REPORT # (B)(4), IN WHICH A CUSTOMER REPORTED THAT THE 130187, SUCTION COAG, F/S, 10FR, 25/CS DEVICE WAS BEING USED DURING AN ADENOIDECTOMY PROCEDURE ON (B)(6) 2023, AND ¿CONMED 10FR SUCTION BOVIE PIECE OF PLASTIC BROKE OFF COMPLETELY AND WAS TEMPORARILY LOST. REPEAT BRONCH AND CONFIRMED THAT NO PLASTIC WAS LEFT IN THE PATIENT¿S AIRWAY. THE PIECE WAS LATER FOUND IN THE SUCTION LINE.¿. FURTHER ASSESSMENT CONFIRMED THAT THE ¿REPEAT BRONCH¿ OCCURRED DURING THE SAME REPORTED EVENT; THERE WAS NOT A SECOND PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION FOR PATIENT OR USER, AND NO EXTENDED HOSPITAL STAY FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581043 ↗
• MalfunctionJan 12, 2024

  CONMED 10FR SUCTION BOVIE PIECE OF PLASTIC BROKE OFF COMPLETELY AND WAS TEMPORARILY LOST. REPEAT BRONCH AND CONFIRMED THAT NO PLASTIC WAS LEFT IN THE PATIENT¿S AIRWAY. THE PIECE WAS LATER FOUND IN THE SUCTION LINE.

  Patient problems: Insufficient Information

  MAUDE report 18501832 ↗
• MalfunctionMay 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE 130187 SUCTION/COAGULATION INSULATION COATING SPLIT. NO SURGICAL DELAYS OR PATIENT INJURY WERE REPORTED. TO DATE, NO ADDITIONAL INFORMATION REGARDING PATIENT STATUS OR PROCEDURE HAS BEEN MADE AVAILABLE. THIS INCIDENT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522894 ↗