MAUDE Adverse Event Report: FIBEROPTICS TECHNOLOGY INC LIGHT GUIDE UNIVERSAL

Catalog Number C3278

Device Problem Human-Device Interface Problem (2949)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint was not confirmed.Examination of the returned used device, item c3278, could not confirm the reported problem.Light guide was tested with ls7700 light source and the light guide performed as intended with no discrepancies noted.The manufacturing documents from the device history record were not reviewed as this is a purchased finished device.(b)(4).Per the instructions for use, the user is advised the following; do not to use the light guide with incompatible equipment or accessories that are not authorized by conmed.Doing so may void certifications and/or warranties.Conmed light guides are not intended for contact with patient.Burn and/or fire hazard.Use of light guide can cause the scope tip to get hot because of high intensity light.Do not allow the light emitting end of the light guide to contact the patient, the surgical drape or any other flammable materials.This can ignite the drape and potentially cause severe burns to the patient and/or operating room personnel.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the c3278, light guide, was attached to 6" retractor, of unknown brand, and the retractor caused a 1st degree burn on the patient's anterior lateral chest, beneath where the retractor was being used.This occurred on (b)(6) 2019 during a breast augmentation surgery.The surgical team was using the retractor with the light guide attached for 45-60 continuous minutes.The retractor did not have any type of protective coating on it and the skin was not protected by any type of damp sponge.The burn was noticed by the surgical team when the retractor was removed from the resting position.The patient was treated with a cool compress and flamazine dressing.Further attempts were made to determine the brand of retractor and its compatibility with the light source, pictures of the retractor were provided, but a brand was not.Although the light guide could be connected to the retractor, this light guide, c3278, is not intended to be used with any type of retractor.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: LIGHT GUIDE UNIVERSAL
• Type of Device: LIGHT GUIDE
• Manufacturer (Section D): FIBEROPTICS TECHNOLOGY INC; #1 quassett road; pomfret CT 06258
• Manufacturer (Section G): FIBEROPTICS TECHNOLOGY INC; #1 quassett road; pomfret CT 06258
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8420545
• MDR Text Key: 142625412
• Report Number: 1320894-2019-00070
• Device Sequence Number: 1
• Product Code: EQH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K904378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C3278
• Device Lot Number: WO131115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1