MAUDE Adverse Event Report: CAREFUSION INC. CROCODILE GRASPER

Model Number	SP8364
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report mw5149633 that their crocodile grasper broke during a laparoscopic cholecystectomy.There was a report of an injury but did not disclose if medical treatment was sought or administered.No report of procedure delay.
Additional Manufacturer Narrative
The reported medwatch mw5149633 did not provide a user facility name, address, phone number or email contact.Without the user facility's contact information, steris is unable to obtain additional information regarding the reported event.The crocodile grasper of the reported event is unavailable for evaluation due to the user facility not being able to be contacted.Without the return or inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: CROCODILE GRASPER
• Common Device Name: 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: 18717126
• Report Number: 1423507-2024-01007
• Device Sequence Number: 14279594
• Product Code: GCJ
• UDI-Device Identifier: 10885403171956
• UDI-Public: 10885403171956
• Combination Product (Y/N): N
• 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): 02/15/2024

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: SP8364
• Device Catalogue Number: SP8364
• 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: 01/18/2024
• Initial Report FDA Received Date: 02/15/2024
• 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