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

Model Number	CFF14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: gyn.Procedure.Event description: 5 mm advanced fixation trocar, cff05, the tip is broken and it happened when insertion of the trocars, gyn.Procedure, lot: 1507555.Additional information received from an applied medical representative via email on 20jan25: was confirmed the device is cff14 lot 1507555.The tm became aware on 13jan25.The product is not returning but would like a replacement.Currently un aware of event date.Additional information received from an applied medical representative via email on 22jan25: tm confirmed it was the obturator tip that was broken that did not cause particulation and the obturator was in the cannula at the time of the incident.It is not known regarding the technique of insertion, the responsible nurse was not in the room.The trocar as not used robotically.Patient status: the patient was not injured in the incident.
Event or Problem Description
Procedure performed: gyn.Procedure.Event description: 5 mm advanced fixation trocar, cff05.The tip is broken and it happened when insertion of the trocars.Gyn.Procedure.Lot: 1507555.Additional information received from an applied medical representative via email on 20jan25: it was confirmed the device is cff14 lot 1507555.The tm became aware on 13jan25.The product is not returning but would like a replacement.Currently un aware of event date.Additional information received from an applied medical representative via email on 22jan25: tm confirmed it was the obturator tip that was broken that did not cause particulation and the obturator was in the cannula at the time of the incident.It is not known regarding the technique of insertion; the responsible nurse was not in the room.The trocar as not used robotically.Patient status: the patient was not injured in the incident.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured obturator tip.Based on the photograph of the event unit and the description of the event, it is likely the obturator tip fracture was caused by insertion force.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 21246870
• Report Number: 2027111-2025-00331
• Device Sequence Number: 3627540
• Product Code: GCJ
• UDI-Device Identifier: 00607915124618
• UDI-Public: (01)00607915124618
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K083638
• 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): 05/19/2025

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: CFF14
• Device Catalogue Number: 101473833
• Device Lot Number: 1507555
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown