MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF71
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robot partial nephrectomy event description: "during the setup of the robot, 8mm robot's trocar was inserted into our ctf71 trocar.At the beginning of the procedure, they noticed that our trocar was broken and a piece of it fell into the patient's abdomen.At the end of the surgery, the surgeon examined the area and got the piece of the trocar out in the bag with the specimen." no patient injury.The patient was released home feeling well.The product is available for return.Additional information received from distributor via email on 17apr2024: "the trocar was inserted by rotating in alternating clockwise and counterclockwise.They report there was no difficulty during insertion.The robot was da vinci si." intervention: took out from the patient abdomen the piece of the broken trocar patient status: was released home.
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 specifications.Based on the condition of the returned unit, it is likely that the reported event was due to uneven wall thickness of the cannula which could cause the cannula to be more susceptible to fracture.
Event or Problem Description
Procedure performed: robot partial nephrectomy.Event description: "during the setup of the robot, 8mm robot's trocar was inserted into our ctf71 trocar.At the beginning of the procedure, they noticed that our trocar was broken and a piece of it fell into the patient's abdomen.At the end of the surgery, the surgeon examined the area and got the piece of the trocar out in the bag with the specimen." no patient injury.The patient was released home feeling well.The product is available for return.Additional information received from distributor via email on 17apr2024: "the trocar was inserted by rotating in alternating clockwise and counterclockwise.They report there was no difficulty during insertion.The robot was da vinci si." intervention: took out from the patient abdomen the piece of the broken trocar.Patient status: was released home.

• Brand Name: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• 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: 19249872
• Report Number: 2027111-2024-00619
• Device Sequence Number: 6590491
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)260407(30)01(10)1488474
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 04/07/2026
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1488474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2023
• 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: DA VINCI SI
• Patient Sex: Unknown