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

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
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: oophorectomy.Event description: on wednesday, (b)(6) 2025, during surgery on patient [name], performed by dr.[name], a structural defect was detected in one of the 12 mm trocars in the kit.One of the tips broke after the surgery began, remaining dangling for approximately 30 minutes before finally falling into the patient's abdominal cavity.Additional information obtained from distributor on 30jul2025: the bend/break did not cause particulation.It was identified during use; it was inside the patient's cavity when a part detached.The trocar was inserted by turning.There was not difficulty during insertion.The trocar was not used with a robot.The obturator was not inserted in the cannula at the time of the incident.Additional information obtained from distributor on 30jul2025: they did remove the piece that had fallen into the abdomen.Intervention: they used another trocar of the same brand.Patient status: patient is in normal condition.
Event or Problem Description
Procedure performed: oophorectomy.Event description: on wednesday, (b)(6) 2025, during surgery on patient [name], performed by dr.[name], a structural defect was detected in one of the 12 mm trocars in the kit.One of the tips broke after the surgery began, remaining dangling for approximately 30 minutes before finally falling into the patient's abdominal cavity.Additional information obtained from distributor on 30jul2025: the bend/break did not cause particulation.It was identified during use; it was inside the patient's cavity when a part detached.The trocar was inserted by turning.There was not difficulty during insertion.The trocar was not used with a robot.The obturator was not inserted in the cannula at the time of the incident.Additional information obtained from distributor on 30jul2025: they did remove the piece that had fallen into the abdomen.Intervention: they used another trocar of the same brand.Patient status: patient is in normal condition.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula tip.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records were performed, and no relevant documentations were identified.

• 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: 22834529
• Report Number: 2027111-2025-00699
• Device Sequence Number: 11903325
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: CFS12
• Device Catalogue Number: 101245401
• Device Lot Number: 1553366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5X100 MM APPLIED MEDICAL TROCARS.
• Patient Sex: Unknown