MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-13 for D-VIEW RETRACTOR SYST PANEL 5IN FIBEROPT 88-1005K manufactured by Carefusion.
[16915682]
The surgeon used the panel 88-1005k together with a diamond view retractor. During the procedure, it got hot on the joint of the retractor and the panel. On this place the material fumed and melted. The surgeon recognized the problem not before he burned his finger. The patient got not harmed. The surgeon continued with the procedure with the same light source, light cable and light retractor with a new panel? And it worked with no further exceptional occurrences.? Neither patient injury nor medical intervention has been reported. (b)(6) 2013, customer informed carefusion that the? Wound of the surgeon got dressed by his team in the o. R.
Patient Sequence No: 1, Text Type: D, B5
[16968289]
(b)(4). The device is being returned to carefusion from the customer. However, the device has not yet been received by carefusion. Once received, the device will be forwarded to the manufacturer for evaluation. A follow up will be sent if the instrument is received and an evaluation of the device is completed.
Patient Sequence No: 1, Text Type: N, H10
[22502361]
(b)(4). The complaint device was returned by the customer and an evaluation was performed. It was observed that the material on the top of the neck area is melted. It was confirmed that the material had melted at the entry to the 90? Bend of the panel and it appears that the material started to burn at this location. There was no foreign material observed on the surface of the panel. As the panel had to be decontaminated, anything present would have been removed. It appears that the damage was caused by a? Black body? , which occurred at the bend in the guide. An attempt was made to recreate this situation using two different light sources along with marked and unmarked light guides. With the light guide clean and properly connected to a recommended light source operating at recommended wattage, there was no evidence of melting or deformation observed. Even when connected to a high output source operating at its highest setting, the clean guide produced no discernable heat. However, with a? Black body? Present at the bend; the guide will overheat as the light energy is absorbed. With a stronger source the increase in temperature was more rapid. The effect will tend to accumulate as the plastic begins to burn and further darkens the spot. Operation at full power resulted in elevated temperatures at the bend in the guide with a? Black body? Present. The root cause was determined to be due to a condition called the? Black body? Effect, meaning that there was some form of contamination on the radius area of the light device. Contamination of blood or fluids have been proven to result in a buildup of concentrated light energy in the radius area, which if allowed to remain on the surface will increase the temperature to a point where melting/burning of the poly material can occur. The area should remain free of contamination and dried blood/body fluids or surgical liquids. A review of the complaint system was performed for this device over the last five years. There have been no other reported complaints of any kind for this device during this time period. The reported issue will continue to be trended and evaluated by carefusion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2014-00011 |
| MDR Report Key | 3570226 |
| Report Source | 06 |
| Date Received | 2014-01-13 |
| Date of Report | 2014-01-18 |
| Date of Event | 2013-12-10 |
| Date Mfgr Received | 2013-12-18 |
| Date Added to Maude | 2014-01-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-VIEW RETRACTOR SYST PANEL 5IN FIBEROPT |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2014-01-13 |
| Model Number | 88-1005K |
| Lot Number | I02068 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-13 |