MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII SHIELDED BLADED ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
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 removal of left ovarian cyst.Event description: during removal of specimen with a retrieval bag it was noticed on the screen that the trocar was broken at the tip.Bits of the trocar had broken off.Once the trocar had been removed all the pieces made up the trocar.Additional information received from an applied medical representative via email on 18nov2024: patient status is unknown at the time of reporting.The tm stated ' i¿m not sure how i can find this out if the theatre staff don't have this answer.The hospital did report this from their end as well.Additional information received from an applied medical representative via email on 20nov2024: the tm stated that the theatre team were not aware of or did not state there was patient injury.Intervention: removed the trocar from patient and continued to finish the procedure.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: laparoscopic removal of left ovarian cyst.Event description: during removal of specimen with a retrieval bag it was noticed on the screen that the trocar was broken at the tip.Bits of the trocar had broken off.Once the trocar had been removed all the pieces made up the trocar.Additional information received from an applied medical representative via email on 18nov24: patient status is unknown at the time of reporting.The tm stated ' i¿m not sure how i can find this out if the theatre staff don¿t have this answer.The hospital did report this from their end as well.Additional information received from an applied medical representative via email on 20nov24: the tm stated that the theatre team were not aware of or did not state there was patient injury.Additional information received from an applied medical representative via email on 16dec24: the trocar was inserted ' with rotation while in advancing in the cavity' and there was no difficulty during insertion.The trocar was not used with a robot.It was confirmed the only instrument that was inside of the cannula at the time of the incident was a specimen bag.Regarding patient ' no visible injury noted after the trocar was broken'.Intervention: removed the trocar from patient and continued to finish the procedure.Patient status: no visible injury noted after the trocar was broken.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with two (2) pieces of a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The clear fragments were 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.

• Brand Name: KII SHIELDED BLADED ACCESS SYSTEM
• 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: 20826747
• Report Number: 2027111-2024-00936
• Device Sequence Number: 9830645
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/28/2025

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: CFB33
• Device Catalogue Number: 101477621
• Device Lot Number: 1526989
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2024
• 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: SPECIMEN RETRIEVAL BAG.
• Patient Sex: Unknown