MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER CROCODILE GRASPER

Model Number	SP8364
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a piece of the snowden-pencer crocodile grasper broke off and fell onto the patient.It is unknown if additional medical intervention was needed to retrieve the broken piece.No report of injury.
Additional Manufacturer Narrative
(b)(6) 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 snowden-pencer crocodile grasper subject of the reported event.The instruction for use states, "all devices must be examined for full functionality prior to and after use.Moving parts of the device should be easily operable.Inspect devices for broken, cracked, discolored, or tarnished surfaces.Inspect for hindered movement of hinges, loose components, and chipped or worn parts.Inspect insulation for breaks or damage.If any of these conditions appear, do not use the device.Return devices to an authorized snowden-pencer representative for repair or replacement." a follow-up report will be submitted should additional information becomes available.No additional issues have been reported.
Additional Manufacturer Narrative
The snowden-pencer crocodile grasper was returned for evaluation following the reported event.Evaluation results determined that the distal tip (fixed jaw, moveable jaw, and pivot pin) had separated from the actuating rod.The pin that joins the moveable jaw and the pin that joins the actuating rod were not returned with the snowden-pencer crocodile grasper.As all components of the device were not returned, a root cause could not be determined.The device history record (dhr) for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER CROCODILE GRASPER
• Common Device Name: CROCODILE 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: 18241919
• Report Number: 1423507-2023-01002
• Device Sequence Number: 6644272
• Product Code: GCJ
• UDI-Device Identifier: 10885403171956
• UDI-Public: 10885403171956
• 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,Followup
• 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: SP8364
• Device Lot Number: LOT # H22
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/28/2024
• 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