MAUDE Adverse Event Report: CAREFUSION INC. FIBEROPTIC RETRACTOR HANDLE

Model Number	88-1087
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fiberoptic retractor handle subject of the reported event is being returned for evaluation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported while utilizing a fiberoptic retractor handle during a patient procedure, a nurse observed a "burn" on the patient's skin.Ointment was applied to the area and the patient procedure was completed successfully.
Additional Manufacturer Narrative
The fiberoptic retractor subject of the reported event was returned for evaluation.Evaluation of the device determined that the root cause is due to user facility personnel using the incorrect cable size with the fiberoptic retractor.User facility personnel were utilizing a 5mm size instead of a 3.5mm.The instructions for use states, "1) these devices must only be used with a 3.5mm size fiber optic bundle cable.Do not use this device with a larger size cable.Failure to use the correctly sized cable will cause the metal connectors of the device/cable to become hot during use, and increased the potential of a thermal burn, and 2) this device transmits high energy light.The metal connectors of the fiber optic bunder and the exposed tip may become hot during use.Never lay the device on a patient or on patient drapes." the device history record (dhr) was reviewed, and no abnormalities were noted.A complaint review determined this to be an isolated event for the subject lot.User facility personnel were counseled on the proper use and operation of the fiberoptic retractor and the importance of using the correct cable size.No additional issues have been reported.

• Brand Name: FIBEROPTIC RETRACTOR HANDLE
• Common Device Name: FIBEROPTIC RETRACTOR HANDLE
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19034054
• Report Number: 1923569-2024-01007
• Device Sequence Number: 8167339
• Product Code: FDG
• UDI-Device Identifier: 10885403151668
• UDI-Public: 10885403151668
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 88-1087
• Device Catalogue Number: 88-1087
• Device Lot Number: D20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown