MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: bladder neck dissection during laparoscopic radical prostectomy.Event description: during the dissection of the bladder neck, the tip of the trocar fragmented and these fragments had to be located and removed.Clinical impact to the patient: none, it was verified that the fragments removed in their entirety corresponded to those detached from the tip of the trocar.Additional information received by applied medical representative via email 20jun24: the bend/break was identifies during use.The trocar rotate in alternating clockwise and counterclockwise direction during insertion and there was no difficulty during insertion.The trocar was not used with a robot.It is confirmed it was the canula tip that fragmented.Grasper was used inside the cannula at the time of the incident.Type of intervention: the affected trocar is removed and replaced with a new one patient status: favorable.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
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 cannula tip fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely that the cannula tip fractured was due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.A historical trend analysis and review of production records was performed and no relevant documentation was identified.
Event or Problem Description
Procedure performed: bladder neck dissection during laparoscopic radical prostectomy event description: during the dissection of the bladder neck, the tip of the trocar fragmented and these fragments had to be located and removed.Clinical impact to the patient: none, it was verified that the fragments removed in their entirety corresponded to those detached from the tip of the trocar.Additional information received by applied medical representative via email 20jun24: the bend/break was identifies during use.The trocar rotate in alternating clockwise and counterclockwise direction during insertion and there was no difficulty during insertion.The trocar was not used with a robot.It is confirmed it was the canula tip that fragmented.Grasper was used inside the cannula at the time of the incident.Type of intervention: the affected trocar is removed and replaced with a new one patient status: favorable.

• Brand Name: CFF33, 11X100 KII FIOS ADVFIX 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: 19580357
• Report Number: 2027111-2024-00703
• Device Sequence Number: 7279253
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874(17)270326(30)01(10)1519130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1519130
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCISSOR AND GRASPER
• Patient Sex: Unknown