MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES Kii Sleeve; Laparoscope, General & Plastic Surgery

Model Number	CFS02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic surgical procedure.Event description: complaint along with swissmedic user report form was received from customer via an applied medical rep via email on 22jan2026.Same information was received by pcf via an applied medical rep via email on 22jan2026 with translation: several plastic particles were detected in the surgical site.The particles clearly originated from the trocar used and had not been present in the operative area beforehand.After the incident was identified, the surgical procedure was interrupted to allow for a thorough inspection of the site.Due to the necessary additional measures, there was a delay in the surgical procedure.As a result of the prolonged duration of the operation, an extended anesthesia time was required.Had the plastic particles remained undiscovered in the surgical site, the following potential risks could have occurred: foreign body reactions, inflammatory processes or infections, abscess formation.The surgical procedure was interrupted to allow for a thorough inspection of the site and all visible plastic particles were completely removed from the surgical area.Longer operation meant extended anesthesia time.Additional information by an applied medical rep, via email on 23jan2026: the report mentions a potential patient injury because plastic particles were found in the surgical site and had to be removed.However, the patient¿s postoperative status was good and no clinical harm was identified.Therefore, the ¿injury¿ refers to the incident itself (foreign material in the wound), not to a lasting adverse outcome for the patient.The procedure did not change.The surgery took longer because additional steps were required: locating all visible plastic fragments, removing the fragments, performing an extended inspection of the surgical site.So, the type of procedure remained the same; only the duration increased due to these necessary measures.The initial planned procedure was a laparoscopic surgical procedure.Additional information by an applied medical representative, via email on 06feb2026 "[both original and translated version available in attachments]": if the shaft was affected, was the obturator in the sleeve at the time of the incident? no, when we discovered the broken part in the abdomen, there were instruments in the abdomen.In the normal surgical procedure.All trocars were inserted with rotational movements and there were no noticeable or reported difficulties.No robot used the basic gynaecological instruments were used throughout the entire operation.These are 5 mm instruments and a 10 mm optic.No incidents were apparent here either.There were no defects or problems.Fedex collection took place this morning.Intervention: the surgical procedure was interrupted to allow for a thorough inspection of the site and all visible plastic particles were completely removed from the surgical area.Longer operation meant extended anesthesia time.Patient status: good.
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 ; +1(949)713-5359
• MDR Report Key: 24309885
• Report Number: 2027111-2026-00353
• Device Sequence Number: 9652361
• 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): N
• 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): 09/25/2026

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: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1569922
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5 MM INSTRUMENTS, 10 MM OPTIC.
• Patient Sex: Unknown