MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CNGL3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: genetic predisposition to malignant neoplasm.Detailed description of event: the device was used correctly without forcing, an internal transparent piece of one of the trocars fell into the surgical field, they put the piece back in the trocar and continued with the use of the device without problem.Type of intervention: an internal transparent piece of one of the trocars fell into the surgical field,they put the piece back in the trocar and continued with the use of the device without problem.Patient status: unknown.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided.Visual inspection confirmed the customer's experience as the shield was fully dislodged from the sleeve.Based on the provided images, it is likely that the reported event was caused by an instrument that was inserted or removed through the seal subassembly in a non-axial manner.The instruction for use (ifu) states that ¿all instruments should be centered axially when inserted through the sleeve¿s seal to avoid potential damage to sleeve.¿.
Event or Problem Description
Name of procedure being performed: genetic predisposition to malignant neoplasm.Detailed description of event: the device was used correctly without forcing, an internal transparent piece of one of the trocars fell into the surgical field, they put the piece back in the trocar and continued with the use of the device without problem.Type of intervention: an internal transparent piece of one of the trocars fell into the surgical field,they put the piece back in the trocar and continued with the use of the device without problem.Patient status: unknown.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• 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: 19112140
• Report Number: 2027111-2024-00543
• Device Sequence Number: 20614952
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)261012(30)01(10)1506426
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191866
• 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): 07/12/2024

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 Model Number: CNGL3
• Device Catalogue Number: 101473942
• Device Lot Number: 1506426
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2023
• 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: SURGICAL INSTRUMENTS AND ULTRASONIC DEVICE
• Patient Sex: Unknown