MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-04-13 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1188 manufactured by Carefusion, Inc.
[42543129]
(b)(4). If further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[42543130]
Regulatory report from the customer received stated, a patient underwent extensive revision at site of prior right breast reconstruction and repair of 2 ventral hernias. A lighted retractor, used to illuminate the surgical site, was placed on patient's abdomen when not in use. It was reported that the handle of the fiber optic cable was emitting heat when off, and that it caused a thermal injury. Patient is a white, (b)(6) female. Although multiple attempts were made to obtain further information; no response was received from the customer.
Patient Sequence No: 1, Text Type: D, B5
[46766749]
(b)(4): the 88-1188 tebbetts fiberoptic ss retractor was not received for evaluation nor was a photo of the instrument provided. A lot number or date code was also not provided; therefore, a dhr review could not be performed. Per information provided it is most probable that the device was of the old design retractor that would heat up and cause burns if the device was utilized with an incorrect size light cord or was laid on a patient? S skin. It is unknown as to what size light cable was utilized with the breast retractor when the incident occurred. The products information, ifu 26-0067 rev d states in the warning section:? These devices must only be used with a 3. 5mm size fiber optic bundle cable. Do not use this device with a larger size cable. Failure to use the correctly sized cable will cause the metal connectors of the device / cable to become hot during use and increases the potential of a thermal burn. 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.? The customer did not follow the ifu which contributed to failure and patient injury. The root cause was misuse of the device by the customer. This reported customer misuse has been previously identified with the lighted tebbetts breast retractor family projects were completed to address complaints associated with the lighted tebbetts breast retractor family related to patient burns and an improved design has been implemented to prevent user error. The new design is currently being distributed for sale. It has been recommended to review the products information, ifu 26-0067 rev d which was included with the packaging of the old design of this device in particular the warning, caution and processing sections for proper use, handling and care. Bd will continue to trend and monitor this reported issue and for this product family.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2016-00079 |
| MDR Report Key | 5573862 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-04-13 |
| Date of Report | 2016-03-22 |
| Date of Event | 2016-02-03 |
| Date Mfgr Received | 2016-05-04 |
| Date Added to Maude | 2016-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628063 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER GA 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 | 2016-04-13 |
| Model Number | 88-1188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-13 |