MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; TROCAR

Model Number	8888561050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the blue handle of the trocar has broken off three times in a row.No patient was harmed.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample we were unable to perform a thorough investigation to determine the root cause or implement any corrective action.We were unable to confirm the reported condition.No root cause can be determined.A corrective and reported action (cap)a will not be initiated.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Additional information: h6 type of investigation code was added.

• Brand Name: ARGYLE
• Common Device Name: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048
• MDR Report Key: 18397915
• Report Number: 9611018-2023-00637
• Device Sequence Number: 3968253
• Product Code: DRC
• UDI-Device Identifier: 10884521029293
• UDI-Public: (01)10884521029293(17)280626(10)23F179FHX
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2024

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
• Device Model Number: 8888561050
• Device Catalogue Number: 8888561050
• Device Lot Number: 23F179FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 12/13/2023; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/25/2024; 02/02/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown