MAUDE Adverse Event Report: BLACK & BLACK SURGICAL, INC. TEBBETTS FIBEROPTIC RETRACTOR; RETRACTOR, FIBEROPTIC

Model Number B61088

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: TEBBETTS FIBEROPTIC RETRACTOR
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): BLACK & BLACK SURGICAL, INC.; 5238 royal woods parkway; suite 170; tucker GA 30084
• Manufacturer Contact: cynthia rees ; 5238 royal woods parkway; suite 170; tucker, GA 30084 ; 7704144880
• MDR Report Key: 6456971
• MDR Text Key: 71626286
• Report Number: 3006142527-2017-00001
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: B61088
• Device Catalogue Number: B61088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FIBEROPTIC LIGHT CABLE 5 MM SN: (B)(4)