LightWave IA-2379Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10845854040355), received between Apr 21, 2017 and Aug 17, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273490 ↗
• MalfunctionAug 17, 2026Material Fragmentation

  The customer reported that the IA-2379, LIGHTWAVE ABLATOR, 90° ANGLE, 3.2 MM X 150 MM device was being used on (b)(6) 2026 and ¿the ablation tip ruptured at the posterior portion during the acromioplasty procedure while operating at settings of 60 Cut / 30 Ablation. A fragment detached and fell into the patient; however, it was completely retrieved and removed during the procedure.¿ There was no report of injury, medical intervention or extended hospitalization for the patient or user. The procedure was completed with an alternate same device and there was a 10-minute delay.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 50273441 ↗
• MalfunctionOct 16, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, IA-2379, LIGHTWAVE ABLATOR, 90° ANGLE, 3.2 MM X 150 MM, WAS BEING USED DURING A BIO ACROMION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿IT WAS REPORTED BY DISTRIBUTOR THAT IT WAS IDENTIFIED THAT THE RADIOFREQUENCY EQUIPMENT USED DURING THE SURGICAL PROCEDURE PRESENTED SURFACE PEELING, WITH ENERGY LEAKAGE THROUGH THE OPENING. FRAGMENTS WERE REMOVED DURING THE PROCEDURE.¿. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED BY USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. 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 23308989 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE IA-2379, LIGHTWAVE ABLATOR, 90° ANGLE, 3.2 MM X 150 MM DEVICE WAS USED IN A BIO ACROMION PROCEDURE ON (B)(6) 2025, AND ¿DURING THE USE OF THE RADIOFREQUENCY DEVICE IN A SURGICAL PROCEDURE, AN EVENT WAS IDENTIFIED AT THE BEGINNING OF ITS APPLICATION. A MALFUNCTION OCCURRED, RESULTING IN AN ABRUPT RELEASE OF ENERGY AND SUBSEQUENT FRAGMENTATION OF THE DEVICE¿S ACTIVE TIP WHILE STILL INSIDE THE PATIENT. THE PROCEDURE WAS INTERRUPTED, AND THE MEDICAL TEAM TOOK THE NECESSARY ACTIONS TO ENSURE PATIENT SAFETY. FRAGMENTS WERE REMOVED DURING THE PROCEDURE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER MANUFACTURER¿S DEVICE AND NO DELAY. FURTHER ASSESSMENT CONFIRMED THAT ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION 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 23301774 ↗
• MalfunctionJan 22, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IA-2379, LIGHTWAVE ABLATOR, 90° ANGLE WAS BEING USED ON (B)(6) 2024 AND ¿DURING THE USE OF RF, THE DEVICE'S PROTECTIVE SHEATH MELTS, CAUSING NO INJURY TO THE PATIENT.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "A PIECE OF THE DEVICE BROKE AND WAS REMOVED FROM THE PATIENT; HOWEVER, A SECOND SURGERY WAS NOT REQUIRED.". THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. 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 21206635 ↗
• MalfunctionFeb 5, 2024Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE DEVICE, IA-2379, LINVATEC H/C LIGHTWAVE ABLATOR WAS BEING USED DURING A MENISCECTOMY PROCEDURE ON (B)(6) 2023 WHEN "IT WAS REPORTED THAT DURING THE SURGERY, THE ABLATION OF 1 OF 2 COMPLAINT PRODUCTS KEPT FUNCTIONING WITHOUT PUSHING THE BUTTON IN THE MIDDLE OF THE SURGERY. THEREFORE, THE SURGEON EXCHANGED THE COMPLAINT ABLATOR, BUT THE ABLATION OF THAT PRODUCT WAS FUNCTIONING JUST BY CONNECTING IT TO THE CONSOLE¿. FOLLOW-UP ASSESSMENT FOUND THAT ¿THE SURGEON FINISHED THE SURGERY WITH THESE 2 COMPLAINT PRODUCT SOMEHOW." THE CUSTOMER REPORTED THAT THERE WAS NO INJURY TO THE PATIENT OR USER, AND THE PROCEDURE WAS COMPLETED AS NORMAL, WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH A DELAY OF ¿WITHIN 30 MINUTES¿. 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 18638934 ↗
• MalfunctionFeb 5, 2024Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE DEVICE, IA-2379, LINVATEC H/C LIGHTWAVE ABLATOR WAS BEING USED DURING A MENISCECTOMY PROCEDURE ON 22DEC23 WHEN ¿IT WAS REPORTED THAT DURING THE SURGERY, THE ABLATION OF 1 OF 2 COMPLAINT PRODUCTS KEPT FUNCTIONING WITHOUT PUSHING THE BUTTON IN THE MIDDLE OF THE SURGERY. THEREFORE, THE SURGEON EXCHANGED THE COMPLAINT ABLATOR, BUT THE ABLATION OF THAT PRODUCT WAS FUNCTIONING JUST BY CONNECTING IT TO THE CONSOLE¿. FOLLOW-UP ASSESSMENT FOUND THAT ¿THE SURGEON FINISHED THE SURGERY WITH THESE 2 COMPLAINT PRODUCT SOMEHOW.¿. THE CUSTOMER REPORTED THAT THERE WAS NO INJURY TO THE PATIENT OR USER, AND THE PROCEDURE WAS COMPLETED AS NORMAL, WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH A DELAY OF ¿WITHIN 30 MINUTES¿. 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 18638932 ↗
• MalfunctionDec 14, 2023Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE IA-2379, LINVATEC H/C LIGHTWAVE ABLATOR WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿IT WAS "TRIGGERING" ON ITS OWN EVEN WITHOUT PRESSING THE BUTTON, AND SOMETIMES WHEN ACTIVATED IT ALSO DIDN'T WORK, THE DEVICE WAS CHANGED TWICE, TO SEE IF THE DEFECT WAS IN THE EQUIPMENT, BUT THE ERROR WAS REPEATED. WE WERE INFORMED THAT THERE WAS NO HARM OR INJURY TO THE PATIENT, DID NOT FALL FRAGMENTS ON THE PATIENT. ANOTHER PRODUCT WAS USED TO REPLACE IT; HOWEVER, THEY DECIDED NOT TO USE IT AGAIN. SURGERY TIME WAS AFFECTED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS AN APPROXIMATE 20-30 MINUTE DELAY. THE PROCEDURE WAS COMPLETED AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿THE PATIENT IS DOING WELL, THE DOCTOR WAS ABLE TO CARRY OUT THE COMPLETE PROCEDURE DESPITE THE DEFECT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325694 ↗
• MalfunctionMar 31, 2022Self-Activation or Keying; Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE IA-2379, LINVATEC H/C LIGHTWAVE ABLATOR, WAS BEING USED DURING A VIDEO ARTHROSCOPY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿SURGERY WAS IN PROGRESS AND RADIOFREQUENCY WAS WORKING NORMALLY, AND AFTER APPROX. TWENTY MINUTES BEGAN TO RING, WITHOUT PRESSING THE BUTTON. THE CIRCULATOR IN THE ROOM HAD TO TURN OFF THE DEVICE TO PREVENT FURTHER DAMAGE.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IA-2379 DEVICE WHICH CAUSED A 20-MINUTE DELAY IN THE PROCEDURE. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE TERM ¿RING¿ SAID IN THE INITIAL REPORT WAS MEANT TO SAY ¿RUN¿. 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 13969953 ↗
• MalfunctionSep 1, 2021Melted; Melted

  THE CUSTOMER REPORTED THAT THE IA-2379, LIGHTWAVE ABLATOR WAS USED IN A VIDEO ARTHROSCOPY PROCEDURE ON (B)(6) 2021. ACCORDING TO THE CUSTOMER, ¿THE TIP OF THE PRODUCT, MELTED.¿ THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO INJURY OR IMPACT TO THE MALE PATIENT REPORTED. 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 12411266 ↗
• MalfunctionSep 26, 2019Defective Device; Defective Device

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE IA-2379 DEVICE WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2019 WHEN FLAME WAS VISIBLE COMING FROM THE TIP OF THE DEVICE. THE REPORTER STATED THAT BEFORE USE AND DURING INSPECTION A BLACK DOT WAS NOTICEABLE ON THE DEVICE. IT IS ALSO REPORTED THAT DURING USE THERE WAS "PEELING" THAT OCCURRED ON THE DEVICE. THE REPORTER HAS STATED THAT THERE WERE NO FRAGMENTS THAT FELL INTO THE SURGICAL SITE; THEREFORE, THERE WAS NOTHING TO BE REMOVED/RETRIEVED. THERE WAS NO REPORT OF INJURY TO THE USER OR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124895 ↗
• MalfunctionJul 19, 2018Break; Break

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE IA-2379, LIGHTWAVE ABLATOR, 90 DEGREE ANGLE, 3.2MM X 150MM, DEVICE BROKE IN THE LOWER PORTION DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2018. NO REPORT OF DEVICE COMPONENT COMING INTO CONTACT WITH PATIENT; THEREFORE, NO COMPONENTS HAD TO BE REMOVED. THE REPORTER HAS STATED THAT THERE WAS NO INJURY TO THE PATIENT. ALSO, THERE WAS NO MEDICAL INTERVENTION REQUIRED NOR WAS THERE ANY PROLONGED STAY IN THE HOSPITAL DUE TO THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704290 ↗
• MalfunctionJul 19, 2018Break; Break

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE IA-2379, LIGHTWAVE ABLATOR, 90 DEGREE ANGLE, 3.2MM X 150MM, DEVICE BROKE IN THE LOWER PORTION DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2018. NO REPORT OF DEVICE COMPONENT COMING INTO CONTACT WITH PATIENT; THEREFORE, NO COMPONENTS HAD TO BE REMOVED. THE REPORTER HAS STATED THAT THERE WAS NO INJURY TO THE PATIENT. ALSO, THERE WAS NO MEDICAL INTERVENTION REQUIRED NOR WAS THERE ANY PROLONGED STAY IN THE HOSPITAL DUE TO THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704286 ↗
• MalfunctionJul 19, 2018Break; Break

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE IA-2379, LIGHTWAVE ABLATOR, 90 DEGREE ANGLE, 3.2MM X 150MM, DEVICE BROKE IN THE LOWER PORTION DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2018. NO REPORT OF DEVICE COMPONENT COMING INTO CONTACT WITH PATIENT; THEREFORE, NO COMPONENTS HAD TO BE REMOVED. THE REPORTER HAS STATED THAT THERE WAS NO INJURY TO THE PATIENT. ALSO, THERE WAS NO MEDICAL INTERVENTION REQUIRED NOR WAS THERE ANY PROLONGED STAY IN THE HOSPITAL DUE TO THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704284 ↗
• MalfunctionApr 21, 2017Sparking; Sparking

  THE CUSTOMER REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE LIGHTWAVE ABLATOR WAS CONNECTED TO THE ELECTROSURGICAL GENERATOR AND SET AT 40 WATTS COAGULATION. THE TIP OF THE LIGHTWAVE BEGAN TO BURN WHEN THE DOCTOR USED IT. IN ADDITION, WHEN THE DOCTOR TRIGGERED THE COAGULATION, FIRE FLAKES CAME OUT OF THE ABLATOR. THIS PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY OR SURGICAL DELAY AS A RESULT OF THIS REPORTED ISSUE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION WITH POTENTIAL FOR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6512908 ↗