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

Model Number	CFS02
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	05/30/2025
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: during a cholecystectomy operation, while using a 5 mm trocar from the company applied (ref: cfs02; lot: 1512242; exp: 20.12.2026), the surgeon (name redacted) notices that the trocar no longer holds the gas return.However, he continues to work until he sees the transparent plastic valve protruding into the abdomen.Immediately, before losing it between the intestinal loops, the valve is fished out.Intervention: the valve is fished out.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of shield dislodgment.The clear component was identified to be a shield, an internal plastic component of the seal.Based on the condition of the returned unit and description of the event, it is likely that the dislodged shield was caused by the non-axial insertion or removal of asymmetrical instruments.Applied medical¿s instructions for use (ifu) states that ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: lap.Cholecystectomy.Event description: during a cholecystectomy operation, while using a 5 mm trocar from the company applied (ref: cfs02; lot: 1512242; exp: 20.12.2026), the surgeon (name redacted) notices that the trocar no longer holds the gas return.However, he continues to work until he sees the transparent plastic valve protruding into the abdomen.Immediately, before losing it between the intestinal loops, the valve is fished out.Additional information received from an applied medical representative via email on 20june25: the tm stated ' the questions were sent twice to the surgeon without an answer, he has written the answer as far as he knows'.There are no images available and for applied to check the returned product upon investigation.No specific instrument mentioned no internal seal components was removed or cut in order to inspect the damaged component.Intervention: the valve is fished out.Patient status: ok.

• 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: 22199078
• Report Number: 2027111-2025-00584
• Device Sequence Number: 15384156
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1512242
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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