MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for TEBBETTS FIBEROPTIC SS RETR 19CMX30MM 88-1090 manufactured by Carefusion, Inc.
[53794973]
(b)(4). If further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[53794974]
The customer reported, during a bilateral nipple sparing mastectomy the metal coupling part connecting the light cord to the retractor got hot and burned the patient. The customer further reported, the patient's arm was abducted at 90 degrees, the burns occurred during the procedure while the breast was being retracted upwards and laterally. The connector touched the arm. The same is true for a burn sustained on the breast while performing the contralateral mastectomy. All burns likely occurred while the instrument was in active use or while repositioning of the retractor. The patient suffered three second degree burns, partial thickness, with blisters. Two were on the arm and one was on the breast in the medial location. The burns on the arm were treated with silvadene crȍe and the burn on the breast was treated with excision. The wounds were healing as of the post-op visit with the patient. The patient's medical status after the event was stable. The customer reported to have not read the instructions to this particular lighted retractor, nor did the fellow and first assist, but has been using lighted retractors in their surgical cases about 9-10 years and never had a patient sustain a burn. The retractor has been used 10-15 times in a year. The procedure was completed as planned. The customer reported the facility would be reporting to the fda but did not provide the report number.
Patient Sequence No: 1, Text Type: D, B5
[58855521]
(b)(4): one (1) 88-1090 device was returned for evaluation for a heat issue. Patient was burned during case. The heat came from where the cord connects to the retractor. Please validate if retractor and cord are working properly or are defective. Visual and functional evaluation by the sr. Product engineer and the sr. Quality engineer confirmed the tebbetts retractor device was not working properly. Visual observation of the fiber optic light cable revealed that the fiber optic bundle at the bottom of the blade was totally covered / clogged with unknown black debris which blocked the transmission of light flow. According to ifu 36-6269c /26-0067, rev d in the warning section,? Failure to properly clean the device may limit the light flow and allow the metal connectors of the fiber optic bundle to become hot during use and increase the potential of thermal burn?. The device also must be used with a 3. 5 mm size fiber optic bundle cable. If used with a larger size cable would cause the metal connectors of the device / cable to become hot during use and increase the potential of a thermal burn. It was confirmed by bd that the correct size cable was used. Additionally it was confirmed that this device is of the old design which allowed for the possibility in rare cases to still block the transmission of light and become overheated. The new design whether it was blocked or not does not allow for the device to become overheated. It allows for more efficient heat dissipation and in turn limits the amount of heat energy stored in the metal which contacts the patient? S skin. The result is a 23% decrease in temperature at patient contacting surface. Based on the above information it is safe to say that the uncleanliness of the fiber optic bundles on the tebbetts fiber optic retractor coupled with it being of the older design was the most probable source of the failure. A review of the device history record did not reveal any non-conformances. The device passed all acceptance criteria for release. The uncleanliness of the fiber optic bundles on the tebbetts fiber optic retractor coupled with it being of the older design was the most probable source of the failure. Bd? S recommendation is that the customer review the tebbetts retractor products instructions for use, ifu 26-0067, rev d in particular the warning section, cleaning and maintenance sections for the device. 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 | 1038548-2016-00091 |
| MDR Report Key | 5896601 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-10-24 |
| Device Manufacturer Date | 2014-08-14 |
| Date Added to Maude | 2016-08-23 |
| 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 |
| 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 19CMX30MM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2016-08-23 |
| Returned To Mfg | 2016-08-08 |
| Model Number | 88-1090 |
| Lot Number | 865282 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-08-23 |