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

Model Number	CTS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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: lap cholecystectomy.Event description: "trocar 11 mm z-thread was being used in a lap chole case.The surgeon was trying to insert the introducer through the sleeve when he noticed a small plastic part stuck in the middle of the sleeve.He was not able to remove it, so another sleeve was opened.No clinical impact on the patient".Intervention: a new sleeve was opened patient status: no clinical impact on the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a severed cannula wing tab within the cannula shaft.Based on the condition of the returned unit, the severed wing tab did not originate from the returned cannula as no damages were observed on the returned cannula¿s wing tab.It is possible the wing tab found within the cannula shaft became lodged within the cannula sometime during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were 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: lap cholecystectomy.Event description: "trocar 11 mm z-thread was being used in a lap chole case.The surgeon was trying to insert the introducer through the sleeve when he noticed a small plastic part stuck in the middle of the sleeve.He was not able to remove it, so another sleeve was opened.No clinical impact on the patient".Intervention: a new sleeve was opened.Patient status: no clinical impact on the patient.

• 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: 19845085
• Report Number: 2027111-2024-00762
• Device Sequence Number: 20482455
• Product Code: GCJ
• UDI-Device Identifier: 00607915124267
• UDI-Public: (01)00607915124267
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K060096
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: CTS12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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