MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab.Based on the condition of the returned unit, it is possible that the cannula damage occurred during manufacturing or as a result of customer handling.However, the exact root cause could not be determined.
Event or Problem Description
Procedure performed: (b)(6).Event description: [translation] on 18.1.24 we had a gall bladder removal by endoscopic surgery using the instrument port kii sleeve ref cts22.During the closing phase, the surgeon noticed a piece of the port that had come off the wound with his finger, so there was no foreign body left in the patient.The piece was missing from the mouth of the surgical port sleeve.The broken port is intact and the packages of the ports used in the operation are lot 1496349 and lot 1498812.Additional information received from applied medical representative via complaint form on 29jan24: the operation went without problems, the ports worked well.During the closure phase, the surgeon felt with his finger a loose piece of plastic that had come loose from the gate.The operation had already been performed.The surgeon removed a piece of plastic from the wound.A piece of plastic was brought out whole.They also used another kii fios first entry 12 x 100mm trocar.(ctf73) they can't say which one trocar it was, from where the piece of plastic had come off.The second port lot is 1498812.Trocars were similar.Additional information received from applied medical representative via email on 29jan24: the piece was from the upper part of the cannula that attaches the seal to the port.It is considered a clean break.The trocar rotated in alternating clockwise and counterclockwise direction during insertion.There was no difficulty during insertion.Intervention: the surgeon removed a piece of plastic from the wound.Patient status: patient is doing well.He/she was not harmed in the situation.

• Brand Name: CTS22, 12X100 KII SLEEVE ZTHR 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: 19115972
• Report Number: 2027111-2024-00551
• Device Sequence Number: 17917939
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)260711(30)01(10)1496349
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: 07/11/2026
• Device Model Number: CTS22
• Device Catalogue Number: 101472328
• Device Lot Number: 1496349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• 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: 01/24/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: CTF73
• Patient Sex: Unknown