MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII BALLOON BLUNT TIP SYSTEMKII® 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	Hematoma (1884)
Date of Event	10/09/2025
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: diagnostic lap.Event description: i found out yesterday that my account (b)(4) [facility name], had an issue with one of 12x100 trocars ¿ctf73¿.I was told a pt.Came back in to the hospital on (b)(6) 2025 with a hematoma after a diagnostic lap that was done week and half ago.I¿m not sure if the broken piece was in the incision or found in the abdomen.The piece was the small clear seal part that is about the size of a dime.The or manager took apart a different 12x100 trocar to match the piece found in the patient.I have attached the photo she sent me to give you an idea of what the part looks like.I was told by the or manager [name] that the piece has to be sent to two different places in [facility] before they can ship the piece to applied medical corporate.Additional information provided by applied medical representative on 21oct2025: i found out that the trocar in question was a 12mm hasson trocar.When i looked at their stock of c0r47 these are the two lot numbers that came up.Lot 1562053.Lot 1556663.This is all the information they have given me at this time.Patient status: pt.Came back in to the hospital on (b)(6) 2025 with a hematoma after a diagnostic lap that was done week and half ago.

• Brand Name: KII BALLOON BLUNT TIP SYSTEMKII® 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: 23405462
• Report Number: 2027111-2025-00827
• Device Sequence Number: 17385481
• 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: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 05/28/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown