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

Model Number	88-8335
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The snowden-pencer atraumatic grasper subject of the reported event was returned to the supplier for evaluation.Evaluation results determined that all components, including the pin, were intact within the instrument; no components were missing.As the snowden-pencer atraumatic grasper was found to have all components, the initial report of the pin breaking and falling into the patient was apparently made in error by user facility personnel.The device history record (dhr) was reviewed for the subject snowden-pencer atraumatic grasper and confirmed that the device was manufactured to specifications.No issues were noted.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, the pin on their snowden-pencer atraumatic grasper broke off and appeared to have fallen into the patient.The patient procedure was completed successfully.The patient received an x-ray, and user facility personnel confirmed no device piece was observed.No injury was reported.

• Brand Name: SNOWDEN-PENCER ATRAUMATIC GRASPER
• Common Device Name: ATRAUMATIC 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: 18636532
• Report Number: 1423507-2024-01004
• Device Sequence Number: 7981782
• Product Code: GEI
• UDI-Device Identifier: 10885403219924
• UDI-Public: 10885403219924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 88-8335
• Device Catalogue Number: 88-8335
• Device Lot Number: L22VEO
• 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: 01/03/2024
• Initial Report FDA Received Date: 02/02/2024
• 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