MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2013-12-30 for UNK V. MUELLER manufactured by Carefusion.
[4096551]
This is a follow-up of our phone conversation earlier.? I had informed you that a patient sustained a burn injury from the connection site? Between the retractor itself and the light cord. The retractor is currently in decontamination, being processed and will be kept? For me? To obtain on monday, since i am off tomorrow.? The light source itself has been removed from service. The numbers for the tebbets retractor? Are 88-1087,88-1088 and 88-1090.? The light cord is 88-9727 the light source is a luxtex, mlx by integra. Additional information received from the nurse manager via telephone conversation on (b)(6) 2013. It was reported that one patient was burned. The burn location is unknown. She stated that the burn occurred from the connection site. It is unknown which of the retractors caused the burn. All three were used during the case.
Patient Sequence No: 1, Text Type: D, B5
[11479895]
(b)(4). If the device becomes available for evaluation, a follow-up mdr will be sent.
Patient Sequence No: 1, Text Type: N, H10
[28147436]
Cfn-2013-4126-initially the customer had reported that a patient sustained a burn injury from the connection site between the retractor itself and the light cord. The light cord itself has been removed from service. The numbers for the tebbetts retractor are 88-1087, 88-1088 and 88-1090. The light cord is 88-9727. The light cord is a luxtex, mlx by integra. On 5dec2013, additional information was received from the nurse manager via telephone conversation. It was reported that one patient was burned. The burn location was unknown. She stated that the burn occurred from the connection site. It was unknown which of the retractors caused the burn. All three were used during the case. Device evaluation: three (3) tebbett retractor devices were returned for evaluation for a patient sustained a burn injury from the connection site between the retractor itself and the light cord. They were one (1) each of product number 88-1087, 88-1088 and 88-1090. The 88-1087 device was confirmed to be manufactured in 1995 under lot# c955929: the 88-1088 device was confirmed to be manufactured june 2008 under lot#808292: and the 88-1090 device was confirmed to be manufactured september 2007 under lot# 800361. Therefore, the ages of the customer? S devices range from 5 to 18 year old. It was reported that one patient was burned. The burn location was unknown. The burn occurred from the connection site. It was unknown which retractor caused the burns. All three were used during the case. The customer stated that the light cord was 88-9727. The light source was a luxtex, mlx by integra. Further investigation of the light cord revealed that the light cord was a 5mm which is an incorrect size to use for this product. Per our information for use (ifu) 26-00677-c these devices must only be used with a 3. 5mm size fiber optic bundle cable. Failure to use the correctly sized cable will cause the metal connectors of the device/cable to become hot during used and increases the potential of a thermal burn. Our ifu states? This device transmits high energy light. The metal connectors of the fiber optic bundle and the exposed tip may become hot during use. Never lay the device on a patient or on patient drapes.? Per the customer, the light source itself has been removed from service
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00033 |
| MDR Report Key | 3541883 |
| Report Source | 04,05 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-05 |
| Date of Event | 2013-12-05 |
| Date Mfgr Received | 2014-01-24 |
| Date Added to Maude | 2013-12-30 |
| 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 | 2013-12-30 |
| Returned To Mfg | 2014-01-24 |
| Model Number | UNK V. MUELLER |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 1. Other | 2013-12-30 |