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	Foreign Body In Patient (2687)
Date of Event	09/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: while trocar was in patient, there was a struggle to remove an instrument from the trocar.Multiple attempts were made with pulling and tugging to remove the instrument.When trocar was removed from patient, two black rubber pieces were pulled out of the trocar rendering the trocar broken.Unknown to the surgical team at that time, a smaller clear rubber piece was retained in the patient.After experiencing complications with recovery, patient returned, a cat scan was performed, and imaging identified a retained foreign object.Additional surgery was performed to remove the object.Intervention: a cat scan was performed, and imaging identified a retained foreign object.Additional surgery was performed to remove the object.Patient status: after experiencing complications with recovery, patient returned.

• 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: 23645805
• Report Number: 2027111-2025-00886
• Device Sequence Number: 10123270
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C0R47
• Device Catalogue Number: 101477456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/25/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White