MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
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: hysterectomy.Event description: the trocar was inserted as usual and the pneumoperitoneum was established to begin the procedure.During the procedure inserting a 5mm instrument through the trocar and the noticed the seal detached and the instrument moved the seal forward.They take off the instruments and put away the trocar.To continue they open a new one that has no problem.No damages on the patient.Information received from applied medical representative via email 26sep23: the correct lot number is 1488629.The tm was notified of the event on (b)(6) 2023.Type of intervention: device replacement.Patient status: no damages.
Event or Problem Description
Procedure performed: hysterectomy.Event description: the trocar was inserted as usual and the pneumoperitoneum was established to begin the procedure.During the procedure inserting a 5mm instrument through the trocar and the noticed the seal detached and the instrument moved the seal forward.They take off the instruments and put away the trocar.To continue they open a new one that has no problem.No damages on the patient.Information received from applied medical representative via email 26sep23: the correct lot number is 1488629.The tm was notified of the event on 25 september 2023.Information received from applied medical representative via email 6oct23: a piece fell into the patient, the piece was retrieved from the patient.The piece was clear.The entire component (shield) fell out.They were inserting a needle when the event happened.5mm grasper [name] was used prior to the incident.Internal seal components were no removed or cut, the piece fallen down was removed, then another new trocar open and even if they inserted the needle the seal in this case didn¿t detached or had any problems.Type of intervention: device replacement.Patient status: no damages.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a clear component.Visual inspection confirmed the complainant¿s experience as the dislodged component was identified to be the shield, an internal plastic component of the seal.Based on the description of the event and condition of the returned unit, it is likely that the dislodged shield was caused by non-axial insertion of an asymmetrical instrument through the trocar.Applied medical¿s instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 6/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: 17865327
• Report Number: 2027111-2023-00616
• Device Sequence Number: 5730084
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)260524(30)01(10)1488629
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K041795
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 05/24/2026
• Device Model Number: CTF03
• Device Catalogue Number: 101472912
• Device Lot Number: 1488629
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM INSTRUMENT; NEEDLE, 5MM GRASPER JOHANN
• Patient Sex: Unknown