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

Model Number	SP90-7815
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their snowden-pencer wavy grasper was "sharpish" and may have "impacted" the patient.The user facility did not provide additional details regarding the patient impact.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Additional Manufacturer Narrative
The snowden-pencer wavy grasper subject of the reported event was discarded by user facility personnel and is not available for evaluation.Without the return of the device a cause cannot be determined.The device history record was reviewed for the subject lot and confirmed the lot was manufactured to specifications; no abnormalities were noted.There have been no other similar complaints associated with this lot.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: SNOWDEN-PENCER WAVY GRASPER
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21173540
• Report Number: 1923569-2025-00001
• Device Sequence Number: 4276133
• Product Code: GCJ
• UDI-Device Identifier: 10885403225468
• UDI-Public: (01)10885403225468
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K930667
• 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): 01/16/2025

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: SP90-7815
• Device Catalogue Number: SP907815
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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