MAUDE Adverse Event Report: CAREFUSION, INC DIAMOND-VIEW RETRACTORSYSTEM 6IN; RETRACTOR, FIBEROPTIC

Catalog Number 88-1001

Device Problem Power Problem (3010)

Patient Problem Burn(s) (1757)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial emdr (b)(4).If any additional information or a sample is received a follow up emdr will be submitted.

Event Description

Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar.The surgeon used a fiber optic retractor with a fiber optic light system.The fiber optic cable connector (which attached the retractor to the power source) heated up and transmitted heat to the patient resulting a burn.

Manufacturer Narrative

Supplemental emdr pr # (b)(4).If any additional information or a sample is received a follow up emdr will be submitted.Medical device catalog #: initial device did not match the provided photos.Initial code will be used a the sample was not returned to verify.Investigation results: a physical sample was not available for investigation.The customer provided several photos of the device, connector, and cable but none of the photos verified the product details or showed the laser etching.A lot was not provided for a device history review so we were unable to check to see if there were any issues found during the manufacturing process.The photographs sent by the customer do not depict an 88-1001 retractor, which receives the 88-1004k light source.None of the photographs provided by the customer include a picture of the laser markings of the product code, so it cannot be determined precisely which product code it is, however, based on the shape of the device, and the present of teeth at the distal end of the device, it is mostly one of the following product codes; 88-1086, 88-1087, 88-1088, or 88-1090.Because a complaint sample was not provided by the customer, the complaint failure mode cannot be recreated or confirmed, and the root cause cannot be determined.The following is a suggestion of what may have occurred.Per the instructions for use for the device in the photograph, 36-6269, ¿the device transits high energy light.The metal connectors of the fiber optic bundle and the exposed tip may become hot during use.Never lay the device on a patient or on patient drapes.Never drape or cover the device with any flammable material or item¿.Additionally the ifu states ¿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.These warning along with all the other warnings in the warnings section of this ifu are detailed because the high intensity light that is transmitted through this device and the light panel must be channeled appropriately to avoid excess heat.Light regardless of source or appearance is energy that carries heat, if the interface between the cable and the light panel is covered in a foreign substance, some of the light will strike the foreign substance, and will stop and that light energy will heat up the foreign substance, making the interface excessively hot.A foreign substance or obstruction can be present on either the cable or the light panel, and the heat caused by this obstruction would conduct to the nearby metal of the retractor or cable and could have caused a burn.The photographs provided by the customer of the mating end of the retractor and the fiber optic cable may indicate that either surface may have been dirty or worn down by abrasion and this may have led the surface to build up excess heat.Based on the description of the complaint failure mode as well as the photographs, it is possible either foreign matter or damage to the fiber optic mating surfaces within the junction joining the retractor to the fiber optic cable may have caused this junction to heat up excessively due to a failure to transmit the light from one device to the other properly.Customer is advised, bodily contact with this junction should be avoided, the device should never lay on a patient or patient drapes, and the light sources should be turned off or switched to a minimum setting when not in use.H3 other text : evaluation has been performed.

Event Description

Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar.The surgeon used a fiber optic retractor with a fiber optic light system.The fiber optic cable connector (which attached the retractor to the power source) heated up and transmitted heat to the patient resulting a burn.

• Brand Name: DIAMOND-VIEW RETRACTORSYSTEM 6IN
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 9811550
• MDR Text Key: 193587829
• Report Number: 1423507-2020-00010
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 88-1001
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR