MAUDE Adverse Event Report: CAREFUSION INC. GRASPER, WAVY DOUBLE-ACTION; WAVY GRASPER

Model Number	SP8484
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the tip from their wavy grasper broke off.The tip was retrieved, and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
V.Mueller has made multiple attempts to contact the user facility to obtain additional event information however, the user facility has not responded.A lot number was not provided for the wavy grasper subject of the reported event.The instructions for use states, "prior to use, all devices should be inspected for cracks, scratches, and/or broken components.Ensure insulation is intact.Any interruptions in the insulation may compromise the safety of the device." "do not use snowden-pencer devices if they do not perform satisfactorily or fail testing or visual inspection, which are detailed in the inspection section of these instructions." "be sure the tips are closed and the instrument is pulled straight out until completely clear of the cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula".A follow-up report will be submitted should additional information becomes available.No additional issues have been reported.

• Brand Name: GRASPER, WAVY DOUBLE-ACTION
• Common Device Name: WAVY GRASPER
• 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: 18241933
• Report Number: 1423507-2023-01003
• Device Sequence Number: 6644777
• Product Code: GCJ
• UDI-Device Identifier: 10885403224911
• UDI-Public: 10885403224911
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/30/2023

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: SP8484
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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