MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2017-04-04 for TEBBETTS FIBEROPTIC RETRACTOR B61088 manufactured by Black & Black Surgical, Inc..
[71626286]
It was concluded that the source of the burn could not be 100% determined. It was discovered that the fiberoptic retractor was used with a non black & black light cable. The light cable used (manufacturer unknown, sn: (b)(4)) was determined to be a 5 mm sized fiberoptic bundle. 3. 5 mm fiberoptic light cables are the recommended bundle size to be used with the tebbetts fiberoptic retractors. The 5 mm bundle in a light cable, is larger than the bundle inside the retractor handle. When light is passed through the fibers, the outer fibers that don't hit the fibers in the retractor reflect inside the metal connection point and can cause the metal to heat up. It seems that the customer laid the retractor down on both sides of the patient's abdomen, which in turn caused the thermal burns. The retractor should not be laid down on the patient. This information was, however, not included in the ifu so ifu 25-0524 is being updated to include precautions to only use 3. 5 mm fiberoptic bundles with tebbetts fiberoptic retractors. The ifu will also be updated to include the precaution to not lay the retractor down on the patient.
Patient Sequence No: 1, Text Type: N, H10
[71626287]
Initial notification from dealer was that they received a call from one of their customers regarding a tebbetts fiberoptic retractor (b61087), and that it had burnt a patient whilst in use. (it was later determined that the device was part number b61088) after requesting more information, the deputy theater manager from the hospital described the incident as follows: the surgeon was cleaning the skin of the abdomen of the patient with a wet 30x30 swab and the skin came off and red - superficial burns noted. The surgeon concluded that must be from the light lead of the lighted breast retractor that got hot while using it. The surgeon immediately washed it with saline (room temperature) and asked to get an inadine dressing from the pharmacy. The retractor was sent to synergy for decontamination only and to be checked when it comes back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006142527-2017-00001 |
| MDR Report Key | 6456971 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-17 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-04-04 |
| 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 | MRS. CYNTHIA REES |
| Manufacturer Street | 5238 ROYAL WOODS PARKWAY SUITE 170 |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal | 30084 |
| Manufacturer Phone | 7704144880 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEBBETTS FIBEROPTIC RETRACTOR |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2017-04-04 |
| Model Number | B61088 |
| Catalog Number | B61088 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLACK & BLACK SURGICAL, INC. |
| Manufacturer Address | 5238 ROYAL WOODS PARKWAY SUITE 170 TUCKER GA 30084 US 30084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |