TEBBETTS FIBEROPTIC RETRACTOR B61088

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3006142527-2017-00001
MDR Report Key6456971
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2017-04-04
Date of Report2017-03-17
Date of Event2017-03-06
Date Mfgr Received2017-03-06
Date Added to Maude2017-04-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. CYNTHIA REES
Manufacturer Street5238 ROYAL WOODS PARKWAY SUITE 170
Manufacturer CityTUCKER GA 30084
Manufacturer CountryUS
Manufacturer Postal30084
Manufacturer Phone7704144880
Single Use3
Remedial ActionRB
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTEBBETTS FIBEROPTIC RETRACTOR
Generic NameRETRACTOR, FIBEROPTIC
Product CodeFDG
Date Received2017-04-04
Model NumberB61088
Catalog NumberB61088
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBLACK & BLACK SURGICAL, INC.
Manufacturer Address5238 ROYAL WOODS PARKWAY SUITE 170 TUCKER GA 30084 US 30084


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-04

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