MAUDE Adverse Event Report: CAREFUSION INC. DIAMOND FLEXTRIANGULAR RETRACTOR

Model Number	89-6112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, there was a tear in the rope within their diamond-flex triangular retractor subsequently causing the device to separate.All pieces were successfully retrieved.No report of injury.
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris made multiple attempts to obtain information regarding the reported event from the user facility however, the user facility has not responded.As the user facility has not responded and the subject device was not returned for evaluation, a root cause cannot be determined.No additional issues have been reported.

• Brand Name: DIAMOND FLEXTRIANGULAR RETRACTOR
• Common Device Name: RETRACTOR
• 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: 19471906
• Report Number: 1923569-2024-01010
• Device Sequence Number: 19721335
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: 10885403122835
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/05/2024

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: 89-6112
• Device Catalogue Number: 89-6112
• Device Lot Number: A19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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