MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS12, 11X100 KII Z-THR SLV, 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap.Sleeve gastrectomy.Event description: insertion of the trocar.Trocar broke during insertion.Different trocar was provided to the doctor.Intervention: different trocar was provided to the doctor.Patient status: alive.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit, it is likely that the reported event was due to the wall thickness of the cannula.
Event or Problem Description
Procedure performed: lap.Sleeve gastrectomy.Event description: insertion of the trocar.Trocar broke during insertion.Different trocar was provided to the doctor.Intervention: different trocar was provided to the doctor.Patient status: alive.

• Brand Name: CTS12, 11X100 KII Z-THR SLV, 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: 17725636
• Report Number: 2027111-2023-00591
• Device Sequence Number: 7212939
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267(17)260516(30)01(10)1488610
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K060096
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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 Expiration Date: 05/16/2026
• Device Model Number: CTS12
• Device Catalogue Number: 101472327
• Device Lot Number: 1488610
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: EXCEL J&J
• Patient Sex: Unknown