MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII FIOS FIRST ENTRY; 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	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: diagnostic laparoscopy and appendectomy.Event description: user reported by email that a plastic part broke from the tip of the sheeth.I am in contact to receive further information.Additional information received from an applied medical representative via email on 27jan25: the tm was made aware that parts of the obturator tip came off while inserting the trocar using fios into the patients' abdomen.Additional information received from an applied medical representative via email on 28jan25: updated procedure - diagnostic laparoscopy and appendectomy, concomitant device.The ctf33 was used as fios first entry as usual with a 10 mm optic.Due to the very thick abdominal wall, it was not possible to place the trocar even with great force.The head physician was called to the operating room, who then decided on a minilap as the first access.The ctf33 was then placed under visualization as a working trocar.The damage to the obturator was noticed and the initial access was searched for any remaining plastic parts.Due to the special anatomy, however, no parts could be found.Tm confirmed 'tip of sheeth' was meant the tip of the obturator.The break was not considered a clean break; it was jagged, partially broken and cracked.The trocar was inserted in an alternating clockwise and counterclockwise direction.It was not a robotic case.Camera was inside the cannula at the time of the incident.Patient status: no patient injury or illness reported.
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 obturator tip.Based on the condition of the returned unit and description of the event, it is possible that the fractured obturator was caused by excessive force during insertion due to patient anatomy.However, the exact root cause could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: diagnostic laparoscopy and appendectomy.Event description: user reported by email that a plastic part broke from the tip of the sheath.I am in contact to receive further information.Additional information received from an applied medical representative via email on 27jan25: the tm was made aware that parts of the obturator tip came off while inserting the trocar using fios into the patients' abdomen.Additional information received from an applied medical representative via email on 28jan25: updated procedure - diagnostic laparoscopy and appendectomy, concomitant device.The ctf33 was used as fios first entry as usual with a 10 mm optic.Due to the very thick abdominal wall, it was not possible to place the trocar even with great force.The head physician was called to the operating room, who then decided on a minilap as the first access.The ctf33 was then placed under visualization as a working trocar.The damage to the obturator was noticed and the initial access was searched for any remaining plastic parts.Due to the special anatomy, however, no parts could be found.Tm confirmed 'tip of sheath' was meant the tip of the obturator.The break was not considered a clean break; it was jagged, partially broken and cracked.The trocar was inserted in an alternating clockwise and counterclockwise direction.It was not a robotic case.Camera was inside the cannula at the time of the incident.Patient status: no patient injury or illness reported.

• Brand Name: KII FIOS FIRST ENTRY
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21298453
• Report Number: 2027111-2025-00339
• Device Sequence Number: 15752792
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Model Number: CTF33
• Device Catalogue Number: 101476488
• Device Lot Number: 1532827
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: 10MM OPTIC.
• Patient Sex: Unknown