MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-10-22 for TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE 88-1087 manufactured by Carefusion.
[3910499]
Burn as best can be ascertained, the instrument in question was being used in conjunction with an acmi g93 light cord and a luxtec lx300 light source during a double mastectomy/reconstruction. At one point during the reconstruction portion of the case, the retractor? While still attached to the cord and source, and still on? Was laid on the patient causing two burns to the patient? S body. Hospital biomed is currently evaluating the cord and the light source in conjunction with their manufacturers. Hospital risk management has claimed that they would be willing to release the instrument after their evaluations are completed. Risk management has filed with medwatch. : additional information received from the customer (b)(6) 2013: it was reported that the patient suffered 3 minor burns 2 (two) under the left breast and 1 (one) mid sternum area. The procedure was completed as planned. The luxtec light cord was an acmi? G93 but the customer did not know anything else regarding the cord. .
Patient Sequence No: 1, Text Type: D, B5
[11096130]
(b)(4). The device was not made available b the customer. If the device becomes available a follow-up mdr will be sent in.
Patient Sequence No: 1, Text Type: N, H10
[19128509]
(b)(4) off label use, not following instructions for use. Probable root cause: user error was the root cause of all the incidents in which the customer provided information or a returned sample was available for evaluation. The clinicians were using the retractors improperly and not following one or more of the directions found in the ifu resulting in areas of the device becoming hot enough to cause minor burns. The current device design is such that an improperly sized light cable, improper cleaning, overuse of the light source and other factors may cause the device to become hot. The products information, ifu 26-0067-c 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?.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00027 |
| MDR Report Key | 3423467 |
| Report Source | 04 |
| Date Received | 2013-10-22 |
| Date of Report | 2013-09-25 |
| Date of Event | 2013-09-25 |
| Date Mfgr Received | 2013-09-25 |
| Date Added to Maude | 2013-10-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2013-10-22 |
| Model Number | 88-1087 |
| 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 | 1. Other | 2013-10-22 |