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

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is 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: radical prostatectomy.Event description: the issue became evident during the extraction of the trocar at the end of surgery.At the end of the surgery and the trocar was removed, it was observed that it was broken, a small piece was missing from the tip of the cannula.Additional information received by email on 23aug2024: the trocar was rotated in alternating clockwise and counterclockwise direction during insertion.There was no difficulty during insertion.The break was considered to be a clean break.Broken piece completely removed from the patient.The trocar was not used with a robot.Type of intervention: the trocars are placed again, the pneumo is performed, the surgeon locates the small piece of the trocar and it is extracted.It is verified that the extracted piece fits 100% in the cannula, confirming that it is complete.Patient status: in good condition.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided.Visual inspection of the provided photo confirmed the complainant¿s experience of cannula tip fracture.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.
Event or Problem Description
Procedure performed: radical prostatectomy.Event description: the issue became evident during the extraction of the trocar at the end of surgery.At the end of the surgery and the trocar was removed, it was observed that it was broken, a small piece was missing from the tip of the cannula.Additional information received by email on (b)(6) 2024: the trocar was rotated in alternating clockwise and counterclockwise direction during insertion.There was no difficulty during insertion.The break was considered to be a clean break.Broken piece completely removed from the patient.The trocar was not used with a robot.Type of intervention: the trocars are placed again, the pneumo is performed, the surgeon locates the small piece of the trocar and it is extracted.It is verified that the extracted piece fits 100% in the cannula, confirming that it is complete.Patient status: in good condition.

• Brand Name: KII SLEEVE
• 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: 20103235
• Report Number: 2027111-2024-00817
• Device Sequence Number: 20918005
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Expiration Date: 03/14/2026
• Device Model Number: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1485588
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIGASURE MARYLAND
• Patient Sex: Unknown