MAUDE Adverse Event Report: CONMED CORPORATION LIGHTWAVE SUCTION ABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	IA-2000-S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual examination found insulation coating missing from the distal tip of the electrode and the ceramic tip broken off (damaged).Based on the condition of the returned device, it appears the customer may have damaged the electrode tip by unintended contact with another instrument, leading to a dielectric failure of the insulation.This is a technique-dependent device and the most likely cause of this issue is user-related.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following; light wave ablators must only be used in a conductive fluid medium to avoid insulation damage.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.Do not bury electrode tip and insulator in tissue.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information was recieved on (b)(6) 2019 and was updated with the new information.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Additional information received: on (b)(6) 2019, new information was received stating the patient involved was a pediatric patient and instead of the reported "single" fragment, multiple fragments were left in the patient.The patient still requires no additional surgical intervention or treatment, however, the patient will be monitored by the surgeon.

• Brand Name: LIGHTWAVE SUCTION ABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8613540
• Report Number: 1320894-2019-00179
• Device Sequence Number: 1729526
• Product Code: GEI
• UDI-Device Identifier: 10845854040348
• UDI-Public: (01)10845854040348(17)230410(30)1(10)201804111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2023
• Device Catalogue Number: IA-2000-S
• Device Lot Number: 201804111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other