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

Model Number SP8385

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

The snowden-pencer wavy grasper subject of the reported event was returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure, the snowden-pencer wavy grasper "broke".A piece of the device detached and came into contact with the patient.The piece of the device was immediately retrieved, and the procedure was completed successfully.An x-ray was taken of the patient and user facility personnel confirmed no issues were noted.No report of injury.

Manufacturer Narrative

During evaluation of the returned device, it was found that the distal tip had separated from the actuating rod.The pin that joins the movable jaw to the link, the link, and the pin that joins the actuating rod to the link were not returned for evaluation.Without the return of all components, a root cause cannot be determined.The device was manufactured in 2017 and showed evidence of visible wear and tear.V.Mueller will continue to monitor complaints for similar events.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER WAVY GRASPER
• Type of Device: 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: 18676878
• MDR Text Key: 335019545
• Report Number: 1423507-2024-01005
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP8385
• Device Catalogue Number: SP8385
• Device Lot Number: K17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1