LightWave IA-2000-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10845854040348), received between Oct 19, 2017 and Mar 20, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Melted” (5 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IA-2000-S, LINVATEC SUCTION ABLATOR, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿AFTER THE ELECTRODE IS CONNECTED TO THE HOST, IT WILL CONTINUE TO WORK CONTINUOUSLY WITHOUT THE NEED FOR PRESSING ANY BUTTONS.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. FURTHER ASSESSMENT WAS REQUESTED AND ON (B)(6) 2026, THE SALES REPRESENTATIVE DISCOVERED THAT THE DEVICE HAD AUTO ACTIVATED WHEN FIRST PLUGGED IN FOR USE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647656 ↗
• MalfunctionMar 13, 2026Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IA-2000-S, LINVATEC SUCTION ABLATOR, WAS USED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿THE BUTTON ACTIVATES WITHOUT BEING PRESSED (UPON CONTACT WITH WATER.)¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED USING AN ALTERNATE DEVICE WITH NO DELAY REPORTED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597098 ↗
• InjuryMay 15, 2019Material Fragmentation; Material Fragmentation

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE IA-2000-S, LIGHTWAVE SUCTION ABLATOR, BROKE DURING AN ELBOW ARTHROSCOPY. A PIECE OF PLASTIC DETACHED FROM THE ELECTRODE HEAD. THE INCIDENT OCCURRED AT FIRST USE OF THE DEVICE. THE SETTING WAS SET AT THE STANDARD 80. FURTHER INFORMATION WAS RECEIVED STATING THE PIECE WAS NOT REMOVED FROM THE PATIENT DUE TO ITS SMALL SIZE (2X1MM). IT COULD NOT BE RETRIEVED THROUGH THE SCOPE AND THE DOCTOR COULD NOT JUSTIFY A CONVERSION TO AN OPEN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO REPORTED DELAY THIS REPORT IS BEING RAISED BASED PATIENT INJURY DUE TO THE PIECE NOT BEING RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8613540 ↗
• InjuryNov 2, 2018Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER REPORTED THAT DURING A DIAGNOSTIC ARTHROSCOPY, PARTIAL SYNOVECTOMY IN THE GLENOHUMERAL JOINT THE IA-2000S, LIGHTWAVE SUCTION ABLATOR CAUSED A MINOR BURN. AFTER ADDITIONAL INFORMATION WAS RECEIVED, IT WAS DETERMINED THE PATIENT RECEIVED A 1ST TO 2ND DEGREE BURN ON THE LEFT UPPER ABDOMEN THAT HAD TO BE MEDICALLY TREATED WITH A PRESCRIPTION (FLAMMAZINE) OINTMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS RELEASED BUT WILL HAVE TO CONTINUE WITH DRESSING CHANGES AND APPLICATION OF OINTMENT BY THE FAMILY DOCTOR. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED PATIENT INJURY.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 8032171 ↗
• MalfunctionApr 20, 2018Melted; Melted

  A CUSTOMER REPORTED WHILE USING AN IA-2000-S, LIGHTWAVE SUCTION ABLATOR, IN AN ACL ARTHROSCOPY PROCEDURE, THE DEVICE MELTED. A 15-MINUTE SURGICAL DELAY OCCURRED AS THE SURGICAL SITE WAS EXPLORED TO ASSURE NO DEBRIS WAS LEFT BEHIND. A NEW CAUTERY TIP WAS USED TO COMPLETE THE PROCEDURE AS INTENDED. THIS INCIDENT DID NOT CAUSE HARM OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447607 ↗
• MalfunctionJan 17, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE USER FACILITY REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE IA-2000-S LIGHTWAVE SUCTION ABLATOR WAS SHOCKING THE DOCTOR DURING USE. UPON GATHERING ADDITIONAL INFORMATION, FROM THE CONMED SALES REPRESENTATIVE AND THE USER FACILITY, THIS ALLEGED "SHOCK" DID NOT HARM THE DOCTOR OR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH MINIMAL SURGICAL DELAY. THIS REPORT IS 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 7201862 ↗
• MalfunctionDec 20, 2017Burst Container or Vessel; Detachment Of Device Component; Melted; Burst Container or Vessel; Detachment Of Device Component; Melted

  THE USER FACILITY REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DISTAL TIP OF THE IA-2000-S LIGHTWAVE SUCTION ABLATOR MELTED DURING USE. THE TIP THEN BURST IN THE SHOULDER JOINT, ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 15 MINUTES. NO PATIENT INJURY REPORTED. THIS REPORT IS 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 7135941 ↗
• MalfunctionDec 20, 2017Melted; Melted

  THE USER FACILITY REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE IA-2000-S LIGHTWAVE SUCTION ABLATOR MELTED. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAYS AND NO PATIENT INJURY WAS REPORTED. THIS REPORT IS 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 7135927 ↗
• MalfunctionDec 20, 2017Melted; Melted

  THE USER FACILITY REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE IA-2000-S LIGHTWAVE SUCTION ABLATOR MELTED. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAYS AND NO PATIENT INJURY WAS REPORTED. THIS REPORT IS 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 7135904 ↗
• MalfunctionOct 19, 2017Melted; Melted

  A CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF A USER FACILITY THAT THE IA-2000-S ABLATORS' TIP MELTED DURING A ROTATOR CUFF REPAIR. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO SURGICAL DELAY REPORTED. THE PATIENT DID NOT SUFFER ANY CONSEQUENCES FROM THIS ALLEGED MALFUNCTION. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6961715 ↗