MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS12, 11X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: cholecystectomy event description: [translation]the distal end of the sleeve ruptured inside the patient! fortunately, the surgeon saw the defect and was able to extract the plastic tip from the patient.Additional information received from applied medical rep via email 24apr24: updated intervention, name of procedure and concomitant device.It was clarified it was the cannular part.The trocar was inserted using hansson technique via open laparoscopic surgery with no difficulty during insertion.The trocar was not used with a robot.Camera was inside of the cannula at the time of the incident.Additional information received from applied medical rep via email 26apr24: six units from this batch are currently in quarantine.Type of intervention: extract the plastic tip from the patient patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The cannula tip was missing a fragment.Based on the condition of the returned unit, it is likely that the cannula tip fractured due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: [translation] the distal end of the sleeve ruptured inside the patient! fortunately, the surgeon saw the defect and was able to extract the plastic tip from the patient.Additional information received from applied medical rep via email 24apr24: updated intervention, name of procedure and concomitant device.It was clarified it was the cannular part.The trocar was inserted using hansson technique via open laparoscopic surgery with no difficulty during insertion.The trocar was not used with a robot.Camera was inside of the cannula at the time of the incident.Additional information received from applied medical rep via email 26apr24: six units from this batch are currently in quarantine.Type of intervention: extract the plastic tip from the patient.Patient status: fine.

• Brand Name: CFS12, 11X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19221972
• Report Number: 2027111-2024-00613
• Device Sequence Number: 20882669
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)261126(30)01(10)1508376
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1508376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAMERA
• Patient Sex: Unknown