MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2013-09-23 for UNK V. MUELLER manufactured by Carefusion.
[20354968]
The patient was burned at the connector site for the cord and the lighted retractor. It was initially reported that one cord was involved. Additional information was obtained from the customer on (b)(4) 2013. Patient information - dob (b)(6) 1988, (b)(6) female, (b)(6), breast reconstruction. The patient suffered a small 1st degree burn requiring bacitracin ointment. The case was not delayed and was completed within this surgeon's time guidelines. In both instances, the equipment was found to be intact and functional at the time of surgery. No other devices or instrumentation were required as a result of this. These retractors and light cord have not been repaired or required any third party refurbishing. But? The customer does not know which of the 3 breast retractors caused the burn. The customer is sending in all three instruments 88-1088, 88-1087, 88-1086 for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[20421704]
(b)(4)-three (3) tebbetts breast retractors were returned for evaluation due to a patient burn which involved one of the returned complaint samples. The customer is not sure which one was being used when the patient received the burn. The (b)(4) device was found to be a 1. 5 years old; the (b)(4) and (b)(4) devices were found to be at least 2 years old each. The devices were visually and functionally examined by the qc tech, quality engineer and r&d engineer. Visually, the devices looked worn from use as seen by some of the gold plating around the handle was partially worn off and multiple scratches on the base of the units and on various areas of the devices. The fiber optics were checked and appeared to omit sufficient light. There was some smudge markings on the optics on all three devices but we are unable to quantify how much was present. The optics still was able to omit light. Proper cleaning and maintenance would eliminate what was observed. According to the products information, ifu 26-0067,? Failure to properly clean the device may limit the light flow and allow the metal connectors of the fiber optic bundle to become hot during use and increase the potential of thermal burn? . As per ifu 26-0067,? The breast retractors transmit high energy light. The metal connectors of the fiber optics bundle and the exposed tip may become hot during use. Never lay the device on a patient or on patient drapes. Never drape or cover the device with any flammable material or item. The device should be in the off position when the device is connected to a light source but not actively in use. Failure to do so may cause excessive heating of the metal connectors of the fiber optic bundle and the exposed tip and increase the potential of thermal burn.? The root cause for the reported failure is believed to be end user error. The description of the issue reported is indicative of product being placed on patient with light source in a fully energized state while not in use. The parameters that affect the amount of heat generated on the tebbetts device at the point of connection to the fiber optic cable (the knurled surface on the acmi connector portion) are threefold: the size of the cable, 3. 5mm or 5mm. 5mm cables are not to be used. (note: 3. 5 and 5mm refers to the size of the fiber bundle. The actual outside diameter of the cable is larger because it includes the jacketing material). The power rating on the light source. Led light sources represent best case and it is not recommended to use a xenon light source with a power rating over 300watts. The 300watt xenon light sources are typical though higher wattage is possible. Those with higher wattage are intended to be used for head lamps only. The duration of time in which the device is in contact with the patient? S skin. The shorter the period of time the better. Based on this information and complaints on this type, a project (b)(4)? Tebbetts retractor heat mitigation has been opened. A review of the device history record (s) did not indicate any non-conformances. A 2 year trend analysis of the complaint system was performed for these product codes. The (b)(4) 2 year trend analysis revealed three (3) similar incidents for burns. Two of them the devices were not returned but additional information from the hospital revealed that the end user used an incorrect size light cable in conjunction with the retractors. The other complaint was not confirmed. The (b)(4) 2 year trend analysis revealed no similar complaints for the reported failure during that time period. The reported issue will continue to be trended and evaluated. Our records have been updated to aid in activities should another issue be reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00025 |
| MDR Report Key | 3362774 |
| Report Source | 04,05 |
| Date Received | 2013-09-23 |
| Date of Report | 2013-08-26 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-08-26 |
| Date Added to Maude | 2013-09-23 |
| 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. SNOWDEN PENCER PRODUCTS |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK V. MUELLER |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2013-09-23 |
| Returned To Mfg | 2013-09-13 |
| Model Number | UNK V. MUELLER |
| Lot Number | 842131; 836035; 834897 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2013-09-23 |