MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for TEBBETTS FIBEROPTIC RETRACTOR B61088 manufactured by Black & Black Surgical, Inc..
[136616457]
After evaluation of device, it was determined that the retractor had been damaged by the user. When looking at the fiber surface under magnification, several impact marks and lines can be seen, which suggests that some sort of impact took place. The metal surrounding the fiberoptics has mushroomed slightly. Once damaged, the heat was no longer able to dissipate as designed and the temperature would have risen at the location of the damage. This increased temperature then caused the fiber surface to burn, thus leading to a more substantial failure: in this case, a piece of fiberoptic bundle came off. Based on this evaluation, it can be determined that the failure could not have happened while in contact with the patient, rather possibly during reprocessing or at the time of impact.
Patient Sequence No: 1, Text Type: N, H10
[136616458]
Regarding the fiberoptic retractor, the customer stated that there was "deterioration / breakage of fibres at the distal end of instrument" and because it was unknown if device was in contact with patient during failure, the event is being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006142527-2019-00001 |
| MDR Report Key | 8303203 |
| Date Received | 2019-02-04 |
| Date of Report | 2018-02-04 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2019-02-04 |
| 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 | MS. CYNTHIA REES |
| Manufacturer Street | 5175 S ROYAL ATLANTA DRIVE |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal | 30084 |
| Manufacturer Phone | 7704144880 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TEBBETTS FIBEROPTIC RETRACTOR |
| Generic Name | FIBEROPTIC RETRACTOR |
| Product Code | FDG |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-14 |
| Model Number | B61088 |
| Catalog Number | B61088 |
| Lot Number | K15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK & BLACK SURGICAL, INC. |
| Manufacturer Address | 5175 S ROYAL ATLANTA DR TUCKER GA 30084 US 30084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-04 |