MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-10 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1188 manufactured by Carefusion.
[21724033]
Patient was burnt by fiberoptic cord/handle connector: additional information received from the customer 22oct2014. It was reported that during a bilateral mastectomy with reconstruction (4-41/2 hrs), the patient was burned on the left lateral breast along the incision line.? The patient had a 2nd degree burn? In several spots along the incision line. The most affected area on the? Lateral breast. Most of the burn was? Excised. ? Bactroban was placed on the wound as well as a telfa dressing. During the procedure, the retractor was not wrapped in a wet lap. Per the customer, the instrument was placed on the patient without a barrier. The light source is shut off if not used for prolonged periods of time but will be left on if only put down for a few minutes. The procedure was completed as planned. : additional information received from the sales rep 27oct2014. It was reported that the sales rep went to visit the customer 17oct2014. The sales rep discussed carefusion's ifu (instructions for use) for the tebbetts retractor and gave them a copy. It is unknown whether the instrument will be received for evaluation at this time.
Patient Sequence No: 1, Text Type: D, B5
[22147008]
(b)(4). Should the device become available, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[33272461]
The customer did not return product for evaluation the clinicians were using the retractors improperly and not following 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 the use of improperly sized light cables, improper cleaning, overuse of the light source and other factors may cause the device to become hot. Review of root causes from previous complaints and capa (b)(4) investigation further confirms this root cause as investigations have historically revealed that user error was the root cause of all the incidents in which the customer provided information or a returned sample was available for evaluation. (b)(4). The products information, ifu 26-0067-d 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?. An in-service has already occurred at the customer by the sales rep on 17oct14. The sales rep discussed carefusion's ifu (instructions for use), 26-0067 rev d for the tebbetts retractor and gave them a copy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2014-00049 |
| MDR Report Key | 4239707 |
| Report Source | 05 |
| Date Received | 2014-11-10 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-10-17 |
| Date Added to Maude | 2014-11-10 |
| 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 | BIOMEDICAL ENGINEER |
| 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 FIBEROPTIC SS RETR 15CMX30MM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2014-11-10 |
| Model Number | 88-1188 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-11-10 |