MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER MINI METZ SCISSORS INSERT

Model Number	SP8302
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	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility discarded the device following the procedure.Without the return of the device, a root cause cannot be determined.The user facility provided a lot number (78632); however, this lot does not correspond to any lot manufactured for the sp8302 snowden-pencer mini metz scissors insert.The instructions for use states, "cautions device and device accessories (including insulation) must be inspected prior to use to ensure integrity.Do not use snowden-pencer devices if they do not perform satisfactorily, or fail testing or visual inspection.Avoid mechanical shock or overstressing the devices; this will cause damage." no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure one of the halves of their snowden-pencer mini metz scissors insert broke off into the patient's abdomen.The detached component was successfully retrieved with a grasper.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Contrary to our initial mdr, the supplier was able to confirm the lot number 78632 aligned with a lot manufactured for the model subject of this event (sp8302).The supplier reviewed the lot history record and no abnormalities were noted.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER MINI METZ SCISSORS INSERT
• Common Device Name: SCISSORS INSERT
• 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: 18498111
• Report Number: 1423507-2024-01002
• Device Sequence Number: 12773725
• Product Code: GEI
• UDI-Device Identifier: 10885403184154
• UDI-Public: 10885403184154
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/11/2024

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: SP8302
• Device Lot Number: 78632
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown