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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap anterior resection.Event description: mid way through the case, surgeon uses an artery to grab a gauze to clean the inner port.Camera was inserted subsequently.These steps were repeated several times before the rubber seal came off.No clinical impact to the patient as a result of the event.Additional information provided by applied medical representative on 04-jun-2026: no pieces fell into the patient.No internal seal components were removed or cut to inspect the damaged component.Intervention: a new trocar was opened.Patient status: nothing; no patient injury indicated.
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.

• 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: 25534477
• Report Number: 2027111-2026-00606
• Device Sequence Number: 9661424
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: 1578149
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 02/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTERY, GAUZE, CAMERA.
• Patient Sex: Unknown