MAUDE Adverse Event Report: CONMED CORPORATION LIGHTWAVE SUCTION ABLATOR

Catalog Number	IA-2000-S
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported used device was returned to conmed for evaluation.Visual inspection verified the reported issue.A portion of the ceramic and insulation coating was missing from the distal tip of the electrode.The coating appeared to be burned and slightly decomposed from excessive heat which is likely caused from unintentional contact between the ablator and another instrument.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.A (b)(4) complaint review revealed 8 similar events been reported for this product.In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence of this failure (b)(4).A risk analysis was performed and this failure is deemed acceptable.To prevent the problem from recurring and to reduce the risk of patient injury, the instruction for use (ifu) provide the following safety measures.- when not in use, place the device in a safe and highly visible area not in contact with the patient.Inadvertent activation while in contact with the patient may result in burns.- if any visual defects are noticed in the insulation, or the ceramic/insulation is damaged in any way, stop using the device immediately and replace the device.- use ablators only within prescribed generator settings.High power generator settings, and prolonged use, may result in damage to the insulation, melting of the electrode tip or increased risk of patient burns.Maximum setting: 200 watts "cut" and minimum setting: 50 watts "cut".Maximum setting: 50 watts "coag" and minimum setting: 30 watts "coag".- improper application or use of the dispersive pad may result in a patient burn or poor performance of the ablator.If higher than normal power settings are required, check for obvious defects and proper adhesion.- do not reuse or relocate the dispersive pad after initial application.If dispersive pad relocation becomes necessary during the procedure, always use a new pad.Electrode gel is unnecessary and should not be applied.Risk of patient injury may be minimized by selecting a dispersive pad site that is remote from the heat sources.- examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.- use care when inserting into and withdrawing the electrode from a cannula to avoid the possibility of damage to the devices and/or injury to the patient.- do not insert, withdraw or touch the active tip of the electrode when power is being applied.This may result in an unintended surgical effect, injury, or device damage.This incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
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.

• Brand Name: LIGHTWAVE SUCTION ABLATOR
• Common Device Name: ABLATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 6961715
• Report Number: 1320894-2017-00222
• Device Sequence Number: 719142
• Product Code: GEI
• UDI-Device Identifier: 10845854040348
• UDI-Public: (01)10845854040348(17)220626(30)1(10)201706271
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Catalogue Number: IA-2000-S
• Device Lot Number: 201706271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1