MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-27 for TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE 88-1087 manufactured by Carefusion.
[16309786]
Sales rep? Stated, director of material management reported that this event occurred 6 months ago, just came to her attention as or wants to purchase another retractor. We got or instrument buyer on the phone who reported that he thinks that they used the storz cord that they have on hand, not the s-p. That was all "thet either" knew. This was not previously reported to carefusion in any way. Patient was harmed due to a burn. Additional information received 07apr2015: the sales rep reported the cord was unmarked and will be sent in along with the 88-1087. It was reported that the instrument and cord were both sent out to medical optics, a local repair company, after a reported incident approx. 6 months ago. After several attempts, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[16346565]
(b)(4). If further information becomes available, a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[36869497]
(b)(4): one (1) 88-1087 tebbetts fiberoptic ss retractor received for evaluation a patient was harmed due to a burn. The sales rep reported that this event occurred 6 months ago and it was brought to her attention as or wants to purchase another retractor. This was not previously reported to carefusion in any way. The sales rep visited the facility on (b)(4) 2015 to gather additional information. Additional information received (b)(4) 2015: the sales rep reported the cord was unmarked and will be sent in along with the 88-1087. It was reported that the instrument and cord were both sent out to medical optics, a local repair company, after a reported incident approx. 6 months ago. The 88-1087 device along with the light cord the hospital identified as used when the reported incident occurred 6 months ago were received for evaluation. The device and the light cord were visually examined by the product engineer, manufacturing engineer and quality engineer. The 88-1087 device was confirmed to be almost 3 years old and very worn at the handle as indicated by the gold plating completely worn off and the faded etching markings on the device. The returned light cord was identified as not being carefusion product and measured 5mm or greater which is an incorrect size to use for this product. The 88-1087 tebbetts retractor can only be used with a 3. 5 mm size fiber optic bundle cable. 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?. This reported customer misuse has been previously identified with the lighted tebbetts breast retractor family and a project was completed to address complaints associated with the lighted tebbetts breast retractor family related to patient burns. Also, an improved design has been implemented to prevent user error. The new design is currently being distributed for sale. A review of the device history record did not reveal any non-conformances. The device passed all acceptance criteria for release. Recommendation is for the customer to review the products information, ifu 26-0067 rev d in particular the warning, caution and processing sections for proper use, handling and care. Carefusion will continue to trend and monitor this reported issue and for this product code.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2015-00061 |
| MDR Report Key | 4729823 |
| Report Source | 06,07 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-05-18 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-04-27 |
| 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 | TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2015-04-27 |
| Returned To Mfg | 2015-03-17 |
| Model Number | 88-1087 |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2015-04-27 |