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

Model Number	CTS22
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic inguinal hernia surgery where a mesh needed to be placed.Event description: the porthouse (seal house) broke when a mesh with a grasper was placed through the porthouse (seal house).The black and clear instrument seal fall out and into the patients abdomen.Additional information received from an applied medical representative via email on 08dec2025: tm confirmed 'porthouse' means seal house.Additional information received from an applied medical representative via email on 15dec2025: the patient is ok and the sleeve was replaced.Besides the laparoscopic grasper, no other instruments was used at the time of the incident ¿ but a mesh was being placed with the grasper.All pieces retrieved from the patient which was black and clear in colour.The component fell out as a whole.Components were instrument seal black and clear and double duckbill seal.No internal seal components removed or cut in order to inspect the damaged component.Intervention: the sleeve was replaced.Patient status: ok.
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.

• 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: 23885329
• Report Number: 2027111-2025-00951
• Device Sequence Number: 4669381
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 101472328
• Device Lot Number: 1559526
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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: LAPAROSCOPIC GRASPER.
• Patient Sex: Unknown