MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII FIOS DUAL PACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: not known.Event description: [translation] the trocar broke when it was removed from its packaging.Additional information received by an applied medical rep via email on 19-jun-2026: no patient or user injury as a result of this event.The event occurred upon removal from packaging.The breakage occurred on the stem.It was a clean breakage.The breakage didn't result in the formation of particles.The device is not available for return.Additional information received by an applied medical rep via email on 23jun26: the break occurred in the cannula.Additional information received by an applied medical rep via email on 24-jun-2026: my interlocutor tells me the cannula was also broken.Patient status: no patient status provided, event occurred before use.

• Brand Name: KII FIOS DUAL PACK
• 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: 25637554
• Report Number: 2027111-2026-00619
• Device Sequence Number: 9526356
• Product Code: GCJ
• UDI-Device Identifier: 00607915124090
• UDI-Public: (01)00607915124090
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083638
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: CFF12
• Device Catalogue Number: 101478401
• Device Lot Number: 1583954
• Was Device Available for Evaluation?: No
• 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: 06/12/2026
• Initial Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 03/13/2026
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown