MAUDE Adverse Event Report: CAREFUSION INC. TEBBETTS FIBEROPTIC RETRACTORS LIGHT CABLE

Model Number	88-9760
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned to steris for evaluation.Investigation in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the fiberoptic light cable to their light source was emitting a burning smell while being plugged into the input connector.
Additional Manufacturer Narrative
The snowden-pencer fiberoptic light cable was returned for evaluation following the reported event.After a thorough evaluation, an exact cause of the reported burning could not be determined.The reported event could not be duplicated.The device history record (dhr) for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: TEBBETTS FIBEROPTIC RETRACTORS LIGHT CABLE
• Common Device Name: LIGHT CABLE
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19325912
• Report Number: 1423507-2024-01016
• Device Sequence Number: 12391979
• Product Code: FST
• UDI-Device Identifier: 10885403155253
• UDI-Public: 10885403155253
• 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): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88-9760
• Device Catalogue Number: 88-9760
• Device Lot Number: WO201673
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/26/2024
• 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