MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-07 for LIGHTMAT SURGICAL ILLUMINATOR UA 2550 manufactured by Lumitex, Inc..
[5691473]
Lumitex md lightmax surgical illuminator, model ua2550, was used during the bilateral mastectomy procedure. The illuminator was connected to a gyrus acmi c93 4 mm fiber optic light cable and used an integra luxtec 300 mlx xenon light source. The surgeon performing the procedure noted during the first part of the procedure, there was a burn over the sternum area of the pt. It was further noted (in the supplied form fda 3500 report) that the metal connection between the light cable and the illuminator appeared to have come in contact with the skin in the area of the sternum. The report further stated the burn covered an estimated area of 4 cm x 3 cm in size and appeared to be mostly superficial and partial thickness. It was also reported that an estimated 2 cm x 1 cm portion of the burn injury appeared to be a full thickness r=burn and that there were a couple of very small punctate areas of burn on the left upper chest wall.
Patient Sequence No: 1, Text Type: D, B5
[13199612]
This incident was first reported to lumitex on (b)(4) 2014 via a phone call from complainant (b)(6) from the (b)(6). (b)(6), a clinical engineer, left a voice mail with (b)(4), lumitex quality director. (b)(4) wrote that mr (b)(6) left a voice mail indicating that this was a "courtesy call" to advise of an incident involving a pt who received burns of the second and third degree during a procedure on (b)(6) 2014. (b)(4) conducted a complaint investigation, including a follow up call on (b)(4) 2014 with (b)(6) that confirmed that a lumitex lightmat ua2550 anda luxtec xenon mlx 300 light source were used during the reported procedure. It should be noted that the indications for use (ifu) lists recommended light sources, and the mlx300 light source is not a recommended source. Further, the ifu warns to closely monitor connector heat when not using a recommended light source. During the surgical procedure, the exposed connector made contact with bare skin causing a 4 mm x 3 mm burn. The ifu specifically warns against placing the connector against pt skin to prevent burns. The investigation was closed on 04/17/2014 with no further action after multiple attempts to provide an on-site in-service were repeatedly rejected. This form fda 3500a was generated in response to a medwatch report entered into the medwatch system in march of this year and received at lumitex on 03/10/2015 for the (b)(6) 2014 incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528108-2015-00001 |
| MDR Report Key | 4687259 |
| Report Source | 04 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-03-10 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RONALD BATE |
| Manufacturer Street | 8443 DOW CIRCLE |
| Manufacturer City | STRONGSVILLE OH 44136 |
| Manufacturer Country | US |
| Manufacturer Postal | 44136 |
| Manufacturer Phone | 4402438401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTMAT SURGICAL ILLUMINATOR |
| Generic Name | LIGHTMAT ULTRA THIN |
| Product Code | HJN |
| Date Received | 2015-04-07 |
| Model Number | UA 2550 |
| Catalog Number | NA |
| Lot Number | 102659 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX, INC. |
| Manufacturer Address | STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-07 |