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

Model Number	C0R47
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
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: na.Event description: nurse was checking her supplies prior to the case, found the trocar with removable turquoise ring shoved over balloon down trocar, concern with integrity of balloon.Removed.Grabbed and opened a new trocar.Additional information provided via phone on 09may2025 at 11:30am to applied medical representative by customer: event date is 27apr2025.Product is available for return.Customer requesting credit since lot number is provided.Return is available.Medwatch report (b)(4) received via email on 02jun2025.Intervention: grabbed and opened a new trocar.Patient status: na, event occurred before use.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of the sleeve protector above the balloon.Based on the condition of the returned unit, it is likely that the sleeve protector was moved proximally above the balloon by the user instead of distally off the cannula prior to the use of the trocar.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: na.Event description: nurse was checking her supplies prior to the case, found the trocar with removable turquoise ring shoved over balloon down trocar, concern with integrity of balloon.Removed.Grabbed and opened a new trocar.Additional information provided via phone on (b)(6) 2025 at 11:30am to applied medical representative by customer: event date is 27apr2025.Product is available for return.Customer requesting credit since lot number is provided.Return is available.Medwatch report (b)(4) received via email on 02jun2025.Intervention: grabbed and opened a new trocar.Patient status: na, event occurred before use.

• 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: 22169230
• Report Number: 2027111-2025-00576
• Device Sequence Number: 9254922
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 1541354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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