MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for LIGHT GUIDE UNIVERSAL C3278 manufactured by Fiberoptics Technology Inc.
[142625412]
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.
Patient Sequence No: 1, Text Type: N, H10
[142625413]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00070 |
| MDR Report Key | 8420545 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | FIBEROPTICS TECHNOLOGY INC |
| Manufacturer Street | #1 QUASSETT ROAD |
| Manufacturer City | POMFRET CT 06258 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06258 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT GUIDE UNIVERSAL |
| Generic Name | LIGHT GUIDE |
| Product Code | EQH |
| Date Received | 2019-03-14 |
| Returned To Mfg | 2019-03-08 |
| Catalog Number | C3278 |
| Lot Number | WO131115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIBEROPTICS TECHNOLOGY INC |
| Manufacturer Address | #1 QUASSETT ROAD POMFRET CT 06258 US 06258 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |