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

Model Number	CFS22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: diagnostic lap and washout.Event description: we are contacting on behalf of the gynaecology team at [hospital name] to alert you to a distressing incident where part of your cannula (kii sleeve - cfs22, lot 1524049) broke during our laparoscopic procedure and small fragment remained in the abdomen of a patient.We were unable to locate this despite significant efforts.We would like you to be aware for your own investigations and quality assurance.Patient status: no patient injury or illness reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit were provided, confirming the complainant¿s experience of a fragmented cannula tip.Based on the event description and similar events, it is likely that the cannula tip fragmentation was due to the cannula tip coming into contact with an object or instrument and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fragmentation due to material abnormality.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: diagnostic lap and washout.Event description: we are contacting on behalf of the gynaecology team at [hospital name] to alert you to a distressing incident where part of your cannula (kii sleeve - cfs22, lot 1524049) broke during our laparoscopic procedure and small fragment remained in the abdomen of a patient.We were unable to locate this despite significant efforts.We would like you to be aware for your own investigations and quality assurance.Additional information received from an applied medical representative via email on 03jan24: the surgeon had replied to the tm with the following answers.Event date, procedure, patient status tab updated accordingly.There was no patient injury and the patient was discharged the next day.The break occurred at the tip of the trocar.The trocar was typically rotate, unable to confirm direction of rotation.Comment passed that surgeon sometime finds it challenging to insert.No previous surgeries recalled at the same site, none abdominal.No robot was not for the procedure.The obturator was already removed at the time of incident.The device will be returned as it was disposed of following procedure.When inserting the secondary port, the surgeon does not push down, rather across and aims the ¿sharp end¿ at the end of the primary port that is already inserted.She acknowledged that this could have contributed to the incident we have here.Intervention: we were unable to locate this despite significant efforts.Patient status: no patient injury or illness reported.

• 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: 21093297
• Report Number: 2027111-2025-00310
• Device Sequence Number: 18434697
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: CFS22
• Device Catalogue Number: 101472330
• Device Lot Number: 1524049
• Was Device Available for Evaluation?: No
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown