MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0H12, KII DISSECTING BALLOON, RND, 3/BX; 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	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap col.Event description: normal use during tepp procedure, balloon came loose from trocar when pulled out of patient.Type of intervention: pulled out the balloon manually.Patient status: no harm done.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the customer¿s experience of balloon and sheath detachment.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: lap col.Event description: normal use during tepp procedure, balloon came loose from trocar when pulled out of patient.Type of intervention: pulled out the balloon manually.Patient status: no harm done.

• Brand Name: C0H12, KII DISSECTING BALLOON, RND, 3/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19038656
• Report Number: 2027111-2024-00492
• Device Sequence Number: 7223788
• Product Code: GCJ
• UDI-Device Identifier: 00607915137229
• UDI-Public: (01)00607915137229(17)260828(30)01(10)1501949
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Expiration Date: 08/28/2026
• Device Model Number: C0H12
• Device Catalogue Number: 101474194
• Device Lot Number: 1501949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STANDARD INSTRUMENTS.
• Patient Sex: Unknown