MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF14, 5X75 KII FIOS ADVFIX DP 10/BX; 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	03/15/2024
Type of Reportable Event	Malfunction
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: laparoscopic excision of endometriosis.Event description: complaint product family: trocar, product name: kii fios 5x75mm af dual pack, model number: cff14, lot number: unknown.It is unknown if the event has occurred before use, during treatment or post-treatment of an unknown procedure.It is unknown what action was being performed when the event occurred.Obturator was bendy and did not go down sleeve without force.When able to be inserted into sleeve, fragments of plastic went everywhere.It is unknown if there was any clinical impact to the patient as a result of the event.It is unknown how the user resolved the situation and what other instruments were used when the complaint event occurred.It is unknown if there was a patient injury or illness associated with the complaint event.The patient status is unknown.Additional information was received from territory manager via email on 19-mar-2024: model number was confirmed as cff14 and lot number as 1485863.It was just the one dual pack impacted during use of laparoscopic excision of endometriosis procedure.While introducing the port into the abdomen, the tip was found to be bent during use and on an attempt to straighten it, it got broken (the piece was kept).There was no clinical impact to the patient as a result of the event and another bladed trocar and sleeve were used to resolve the situation.There were no other instruments used when the complaint event occurred.Intervention: used another bladed trocar and sleeve.Patient status: no clinical impact to the patient.
Event or Problem Description
Procedure performed: laparoscopic excision of endometriosis.Event description: complaint product family: trocar, product name: kii fios 5x75mm af dual pack, model number: cff14, lot number: unknown.It is unknown if the event has occurred before use, during treatment or post-treatment of an unknown procedure.It is unknown what action was being performed when the event occurred.Obturator was bendy and did not go down sleeve without force.When able to be inserted into sleeve, fragments of plastic went everywhere.It is unknown if there was any clinical impact to the patient as a result of the event.It is unknown how the user resolved the situation and what other instruments were used when the complaint event occurred.It is unknown if there was a patient injury or illness associated with the complaint event.The patient status is unknown.Additional information was received from territory manager via email on 19-mar-2024: model number was confirmed as cff14 and lot number as 1485863.It was just the one dual pack impacted during use of laparoscopic excision of endometriosis procedure.While introducing the port into the abdomen, the tip was found to be bent during use and on an attempt to straighten it, it got broken (the piece was kept).There was no clinical impact to the patient as a result of the event and another bladed trocar and sleeve were used to resolve the situation.There were no other instruments used when the complaint event occurred.Intervention: used another bladed trocar and sleeve.Patient status: no clinical impact to the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a fractured obturator tip.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is possible that the fractured cannula was caused by force exerted on the cannula tip during the procedure.However, applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.

• Brand Name: CFF14, 5X75 KII FIOS ADVFIX DP 10/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: 19000234
• Report Number: 2027111-2024-00474
• Device Sequence Number: 16912675
• Product Code: GCJ
• UDI-Device Identifier: 00607915124618
• UDI-Public: (01)00607915124618(17)260508(30)01(10)1485863
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 05/08/2026
• Device Model Number: CFF14
• Device Catalogue Number: 101452901
• Device Lot Number: 1485863
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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