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

Model Number	C0R47
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.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: upon receiving the goods, the customer noticed damage on the printed side of the sterilization pouch and therefore returned it to us.Please find the attached photos for your reference.The customer did not use the product during surgery and directly requested us to retrieve it.We have replaced it with a new unit for the customer.Type of intervention: the customer did not use the product during surgery and directly requested us to retrieve it.We have replaced it with a new unit for the customer.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: 21643782
• Report Number: 2027111-2025-00428
• Device Sequence Number: 18048586
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: 1536633
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Date Device Manufactured: 10/07/2024
• 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