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

Catalog Number IA-2000-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The used lightwave ablator was returned to conmed for evaluation on 02-dec-2016.Visual examination using magnification found the device active tip appears to have damage to the ceramic insulator and exhibits a detached portion of the ceramic insulator which was returned with the device.The tan insulation coating exhibits slight damage to the side of the ceramic detachment point.The ceramic appears to have broken off due to twisting force during insertion or retraction from the joint space.The electrode appears to have been used based on the condition of the active electrode showing signs of activation.The detached portion of the ceramic insulator appears to exhibit damage in the same location of the mechanical damage exhibited on the metal active electrode.Lot 201606221 was manufactured on 22-jun-2016.Of the lot containing (b)(4) units there have been no other complaints received.A 2-year review of the device family complaint history showed a total of two (2) complaints for this failure mode involving a quantity of two (2) devices.This is the only adverse event report for this device family for this failure mode.(b)(4).To date, there have been no patient long term adverse events reported regarding any of the reported incidents.This failure mode is addressed in risk documentation and the risk analysis shows an acceptable risk level.All lightwave ablators are intended to be used for ablation, tissue modification and coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.Based on available information, this event did not involve a product problem indicating a nonconformity, adverse trend or unanticipated hazard.At this time, conmed plans no corrective or remedial action.The reported problem will continue to be monitored via the complaint system to ensure product safety.To reduce the risk of insulation damage and injury to the patient, the instructions for use (ifu) provides the following warnings & cautions to the user: lightwave ablators must only be used in a conductive fluid medium to avoid insulation damage.Ensure all accessories are properly & securely connected to the generator & function as intended.Improper connection may result in arcing, sparking, or device failure, any of which can result in an unintended surgical effect, injury, or equipment damage.If any visual defects are noticed in the insulation, or the ceramic/insulation is damaged in any way, stop using the device immediately & replace.Based on available information, this event did not involve a product problem indicating a nonconformity, adverse trend or unanticipated hazard.At this time, conmed plans no corrective or remedial action.The reported problem will continue to be monitored via the complaint system to ensure product safety.

Event Description

The user facility reported during surgery, a piece of the lightwave suction ablator fell into the shoulder of the patient.The piece was able to be retrieved and an alternate device was used to complete the procedure.It was reported there was a 45-minute surgical delay with this product issue and there was no patient injury.To date, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

• Brand Name: LIGHTWAVE SUCTION ABLATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: brenda johnson ; 11311 concept boulevard; largo, FL 33773 ; 7273995515
• MDR Report Key: 6156746
• MDR Text Key: 61866330
• Report Number: 1017294-2016-00127
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K083281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Catalogue Number: IA-2000-S
• Device Lot Number: 201606221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1