MAUDE Adverse Event Report: CONMED CORPORATION LIGHTWAVE SUCTION ABLATOR

Catalog Number	IA-2000-S
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned to conmed for evaluation.Functional testing of the device with a aes-1 generator could not replicated the reported problem.The device was tested in both modes and no fault was found.The device performed as intended with no discrepancies.A review of the manufacturing documents verified the device was 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.A two-year review of complaint history revealed no similar complaints for this product family and failure mode.During this same time frame, (b)(4).A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents.The instructions for use advise the user of the following.- this equipment is capable of producing a physiological effect and is for use only by licensed physicians trained in the use of this device.- 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 arching, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
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.

• Brand Name: LIGHTWAVE SUCTION ABLATOR
• Common Device Name: LIGHTWAVE SUCTION ABLATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7201862
• Report Number: 1320894-2018-00009
• Device Sequence Number: 19056559
• Product Code: GEI
• UDI-Device Identifier: 10845854040348
• UDI-Public: (01)10845854040348(17)220723(30)1(10)201707241
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/23/2022
• Device Catalogue Number: IA-2000-S
• Device Lot Number: 201707241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1