MAUDE Adverse Event Report: CAREFUSION INC. KOLBEL-TYPE RETRACTOR BLADES

Model Number	OS8818-23
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	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported their kolbel retractor broke during a patient procedure.No procedure delay or injury reported.
Additional Manufacturer Narrative
The kolbel-type retractor blade will be returned to steris for further evaluation.Our investigation is in process.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The kolbel-type retractor blade, subject of the reported event was returned for evaluation.The results of the evaluation were inconclusive; no specific root cause could be determined.The device history record (dhr) for the subject unit was reviewed and no abnormalities were noted.A complaint review was performed and confirmed this to be the only complaint for this lot.Per the v.Mueller products and services general surgical instrument cleaning and sterilization guide "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage." the user facility was counseled on the importance of inspecting the device prior to each use.The user facility was provided a replacement retractor blade.No additional issues have been reported.

• Brand Name: KOLBEL-TYPE RETRACTOR BLADES
• Common Device Name: RETRACTOR
• 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: 19281547
• Report Number: 1423507-2024-01015
• Device Sequence Number: 6320369
• Product Code: GAD
• UDI-Device Identifier: 70885403160242
• UDI-Public: 70885403160242
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/09/2024

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: OS8818-23
• Device Catalogue Number: OS8818-23
• Device Lot Number: J23VIN
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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