MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown event description: "last friday dr [name] used one ctf33 during her case and once she inserted the trocar they noticed blood inside the trocar, the blunt trocar is broken and sharp on the distal tip.They checked the packaging and patient for the missing plastic pieces and no traces found" product is available for return.Additional information received on 15nov2023 per health canada report # 1070351: [translation of incident description] the surgeon notices when she enters the operating lens with the trocar that there is liquid coming out through the first entry trocar.This is not normal but still does the surgery before the trocar.At the end of the case we noticed that a small piece of plastic was missing from the trocar cannula.It is assumed that the piece of plastic was missing before surgery but we are not certain.The surgeon checked the abdomen and found no plastic pieces in the abdomen.Additional information received on 16nov2023 via email from account manager: no patient injury occurred.Distal tip of obturator broke.The trocar was inserted using the recommended technique.There was no difficulty during insertion.The case was not robotic.Intervention: they checked the packaging and patient for the missing plastic pieces and no traces found.Patient status: no patient injury occurred.
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.
Event or Problem Description
Procedure performed: unknown.Event description: "last friday dr [name] used one ctf33 during her case and once she inserted the trocar they noticed blood inside the trocar, the blunt trocar is broken and sharp on the distal tip.They checked the packaging and patient for the missing plastic pieces and no traces found" product is available for return.Additional information received on 15nov2023 per health canada report # 1070351: [translation of incident description] the surgeon notices when she enters the operating lens with the trocar that there is liquid coming out through the first entry trocar.This is not normal but still does the surgery before the trocar.At the end of the case we noticed that a small piece of plastic was missing from the trocar cannula.It is assumed that the piece of plastic was missing before surgery but we are not certain.The surgeon checked the abdomen and found no plastic pieces in the abdomen.Additional information received on 16nov2023 via email from account manager: no patient injury occurred.Distal tip of obturator broke.The trocar was inserted using the recommended technique.There was no difficulty during insertion.The case was not robotic.Intervention: they checked the packaging and patient for the missing plastic pieces and no traces found.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken obturator tip.Based on the condition of the returned unit, it is likely that the reported event was caused by the obturator material, which was more susceptible to fracture.

• Brand Name: CTF33, 11X100 KII FIOS ZTHR 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: 18173085
• Report Number: 2027111-2023-00768
• Device Sequence Number: 7687629
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)260724(30)01(10)1494634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 07/24/2026
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1494634
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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
• Patient Sex: Unknown