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

Model Number	C0H12
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	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is 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: tep.Event description: [translation] balloon loosens.Balloon releases.Additional information received from an applied medical representative via email on 19feb2025: the balloon came off the trocar after removal of the c0h12 and got stuck in patient after dissection was created.He removed the balloon with a grasper from the patient.There where two separate incidents that day, they were not with the same patient.The second c0h12 was discarded post procedure.According to him balloon dissection went well and the balloons were intact before removal.No balloon particles were found in both procedures.Intervention: removed the balloon with a grasper from the patient.Patient status: patient is ok.
Event or Problem Description
Procedure performed: tep.Event description: [translation]balloon loosens.Balloon releases.Additional information received from an applied medical representative via email on 19feb25: the balloon came off the trocar after removal of the c0h12 and got stuck in patient after dissection was created.He removed the balloon with a grasper from the patient.There where two separate incidents that day, they were not with the same patient.The second c0h12 was discarded post procedure.According to him balloon dissection went well and the balloons were intact before removal.No balloon particles were found in both procedures.Product was discarded.Intervention: removed the balloon with a grasper from the patient.Patient status: patient is ok.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Based on the description of the event, it is possible the balloon was more susceptible to detachment from the cannula when force was applied.However, the exact root cause could not be determined.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.

• Brand Name: KII DISSECTING BALLOON
• 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: 21463365
• Report Number: 2027111-2025-00383
• Device Sequence Number: 12971876
• Product Code: GCJ
• UDI-Device Identifier: 00607915137229
• UDI-Public: (01)00607915137229
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K182024
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: C0H12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown