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

Model Number	C0R47
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return for evaluation.No lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (before use).Detailed description of event: hospital name: [name] hosp.This is a complaint from the hospital.Foreign material such as hair was found in the syringe.No patient injury or illness associated with this event.Replaced to a new hospital inventory c0r47 and procedure was completed.The investigation report has been requested by the hospital.This event unit will be returned.Type of intervention: replaced to a hospital inventory and the procedure was completed.Patient status: na (no patient involvement).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, and a photo of the event unit was provided by the complainant.Visual inspection confirmed the presence of a loose hair on the device.Based on the condition of the returned unit and the description of the event, it is likely that the loose hair originated from an operator during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Name of procedure being performed: na (before use).Detailed description of event: hospital name: [name] hosp.This is a complaint from the hospital; foreign material such as hair was found in the syringe.No patient injury or illness associated with this event.Replaced to a new hospital inventory (b)(6) and procedure was completed.The investigation report has been requested by the hospital.This event unit will be returned.Type of intervention: replaced to a hospital inventory and the procedure was completed.Patient status: na (no patient involvement).

• 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: 22917088
• Report Number: 2027111-2025-00726
• Device Sequence Number: 9864848
• 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): 10/16/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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