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

Model Number	C0R47
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown, event description: report from the sales rep via email; the balloon did not inflate.Pre-balloon check: no.Product damage.: a hole on the balloon.Robotic case : no.Contact with sharp / high temperature instruments.: ni.Incision size : ni.Concomitant device: ni.How to insert : ni.No patient injury or illness associated with this event.Replaced to another new clinical sample c0r47 and the procedure was completed.This event unit will be returned.Type of intervention: replaced to another new clinical sample c0r47 and the procedure was completed.Patient status: no patient injury or illness associated with this event.
Event or Problem Description
Procedure performed: unknown.Event description: report from the sales rep via email.The balloon did not inflate.Pre-balloon check: no.Product damage.: a hole on the balloon.Robotic case: no.Contact with sharp / high temperature instruments.: ni.Incision size: ni.Concomitant device: ni.How to insert: ni.No patient injury or illness associated with this event.Replaced to another new clinical sample c0r47 and the procedure was completed.This event unit will be returned.Type of intervention: replaced to another new clinical sample 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.Visual inspection confirmed the complainant¿s experience of balloon leakage.The cannula was also observed to be fractured.Based on the condition of the returned unit, it is possible that the balloon leakage and cannula damage was due to instrumentation coming into contact with the trocar and/or excessive force exerted on the trocar during the procedure.However, the exact root cause of the cannula damage could not be determined.Based upon the initial description of the event, the event of balloon leakage is not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical has determined that this event is reportable due to the fractured cannula.A historical trend analysis and review of production records was performed and no relevant trend was identified.

• 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: 21185606
• Report Number: 2027111-2025-00322
• Device Sequence Number: 14508699
• 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): 04/16/2025

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
• Device Catalogue Number: 101477456
• Device Lot Number: 1511728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/16/2025
• Date Device Manufactured: 02/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown