MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic hepatectomy event description: this is a complaint from the hospital; it is difficult to remove the obturator and the seal part fell apart.No patient injury or illness associated with this event.Replaced to a new hospital inventory c0r47 and procedure was completed.This event unit will be returned.Intervention: replaced to a hospital inventory new c0r47 and the procedure was completed.Patient status: no patient injury or illness associated with this event.
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: laparoscopic hepatectomy.Event description: this is a complaint from the hospital.It is difficult to remove the obturator and the seal part fell apart.No patient injury or illness associated with this event.Replaced to a new hospital inventory c0r47 and procedure was completed.This event unit will be returned.Intervention: replaced to a hospital inventory new c0r47 and the procedure was completed.Patient status: no patient injury or illness associated with this event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with seal cap which separated from the seal housing.Visual inspection confirmed the complainant¿s experience of component detachment as seal cap was dislodged from the seal housing.Based on the condition of the returned unit and description of the event, it is likely that the dislodged seal cap was caused by the broken pins of the seal cap.It is also possible that the seal cap was damaged during shipping and handling while in transit.Applied medical has performed a historical trend analysis and review of production records and no trend was identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: KII BALLOON BLUNT TIP SYSTEM
• 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: 22609443
• Report Number: 2027111-2025-00661
• Device Sequence Number: 21358696
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060629
• 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): 12/04/2025

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: C0R47
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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
• Patient Sex: Unknown