MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER

Model Number	88-1087
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.An investigation is currently in process.A follow-up mdr will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that an employee received a "burn" to their glove while using a fiberoptic retractor during a breast implant replacement surgery.No report of injury or procedure delay.
Additional Manufacturer Narrative
The retractor subject of the reported event was returned for evaluation.Evaluation results determined that no issues were noted with the function or operation; the device operated as intended.The device history record (dhr) was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed this to be an isolated event for the subject lot.As no issues were noted with the function or operation of the retractor, the reported event can be attributed to user error.The retractor tebbetts fiber optics instructions for use states, "do not use fiber optic cables larger than 3.5mm.Failure to properly clean the device may limit light flow and allow the metal connectors of the fiber optic bundle to become hot during use and increase the potential for thermal burn." user facility personnel received in-service training on the proper use and operation of the retractor tebbetts fiber optics.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: SNOWDEN-PENCER
• 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: 19772764
• Report Number: 1923569-2024-01012
• Device Sequence Number: 8068636
• Product Code: FDG
• UDI-Device Identifier: 10885403151668
• UDI-Public: (01)10885403151668(10)D20
• 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): 07/18/2024

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: 88-1087
• Device Catalogue Number: 88-1087
• Device Lot Number: (10)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: 06/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/16/2024
• 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