MAUDE Adverse Event Report: CAREFUSION INC. DIAMOND FLEXTRIANGULAR RETRACTOR

Model Number	89-6110
Medical Device Problem Code	Break (1069)
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 diamond flextriangular retractor subject of the reported event has been returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, the internal wire to their diamond flextriangular retractor "broke" when the surgeon was removing the device from the laparoscopic port.An x-ray was taken of the patient and confirmed no device pieces were present.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.During evaluation of the device, it was determined that an unknown third-party service provider had made repairs to the device.The serial number of the handle confirmed that it was from 2013; however, the device itself was manufactured in 2019.During evaluation it was also observed that three components were missing (limiting block, headed pin and set screw).The device was also missing a nipple crimp at the end of the memory wire and the memory wire was too short in length.These observations further indicate that the third-party service provider performed improper repairs to the device.The device history record (dhr) was reviewed and confirmed the device was manufactured to specifications in 2019.A complaint review was performed and confirmed this to be an isolated event.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: 19321546
• Report Number: 1923569-2024-01009
• Device Sequence Number: 7592181
• Product Code: GCJ
• UDI-Device Identifier: 10885403122811
• UDI-Public: 10885403122811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 89-6110
• Device Catalogue Number: 89-6110
• Device Lot Number: A19
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/21/2024
• 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