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

Model Number	CTS22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 cholecystectomy event description: target: all supplies will work as intended.Actual: 12mm trocar was placed in the sterile fasion and while the surgeon was manipulating the trocar it broke along the shaft.The exposed portion of the trocar was removed and the broken portion of the trocar shaft was extracted from the patients abdominal wall.The surgeon, dr.[name], check the abdominal wall for injury and found none.Gap: the trocar should not have broken.Additional information provided by [user facility] on 30jul2024 via email: event occurred 7/20/24.Procedure being performed was laparoscopic cholecystectomy.The color of the piece was clear.[non-applied] grasper was being used prior and at the time of the incident.No picture available of the piece/component.The broken pieces were retrieved from the patient.Intervention: the broken pieces were retrieved from the patient.Patient status: no injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and did not meet specifications.Based on the condition of the returned unit, it is likely that the reported event was due to the wall thickness of the cannula.It is possible that the force applied to the unit during manipulation and the cannula being more susceptible to fracture were contributing factors.Applied medical has performed a historical trend analysis and review of production records and no trends 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: laparoscopic cholecystectomy.Event description: target: all supplies will work as intended.Actual: 12mm trocar was placed in the sterile fasion and while the surgeon was manipulating the trocar it broke along the shaft.The exposed portion of the trocar was removed and the broken portion of the trocar shaft was extracted from the patients abdominal wall.The surgeon, dr.[name], check the abdominal wall for injury and found none.Gap: the trocar should not have broken.Additional information provided by [user facility] on 30jul2024 via email: event occurred 7/20/24.Procedure being performed was laparoscopic cholecystectomy.The color of the piece was clear.[non-applied] grasper was being used prior and at the time of the incident.No picture available of the piece/component.The broken pieces were retrieved from the patient.Intervention: the broken pieces were retrieved from the patient.Patient status: no injury.

• 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: 20024216
• Report Number: 2027111-2024-00786
• Device Sequence Number: 18011613
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1506590
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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