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

Model Number	CNGL3
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.This report is to follow-up medwatch (b)(4).
Event or Problem Description
Procedure performed: hysterectomy abdominal robotic xi.Event description: complaint created based on medwatch received by mail.Report number (b)(4).Gelpoint mini device was not holding appropriate seal for co2 gas during robotic procedure.Removed the gelseal cap and used a new one.Co2 gas seal was maintained with new device.Product not available for return as indicated by medwatch form.Additional information was received via telephone on 14oct2021 from [name]: per the rep, the physician placed a trocar too close to the stop cock.Confirmed that there was no patient injury.Additional information was received via email on 15oct2021 from [name]: the leaking was noticed at the beginning of the case once the insufflator was turned on.No instruments were inserted directly through the gel.It was determined that the trocars were placed to close to the smoke evacuation port.The product was disposed of by the staff.Type of intervention: a new gelseal cap was used to complete the case.Patient status: no patient injury.
Event or Problem Description
Procedure performed: hysterectomy abdominal robotic xi.Event description: complaint created based on medwatch received by mail.Report number (b)(4).Gelpoint mini device was not holding appropriate seal for co2 gas during robotic procedure.Removed the gelseal cap and used a new one.Co2 gas seal was maintained with new device.Product not available for return as indicated by medwatch form.Additional information was received via telephone on 14oct2021 from [name]: per the rep, the physician placed a trocar too close to the stop cock.Confirmed that there was no patient injury.Additional information was received via email on 15oct2021 from [name]: the leaking was noticed at the beginning of the case once the insufflator was turned on.No instruments were inserted directly through the gel.It was determined that the trocars were placed to close to the smoke evacuation port.The product was disposed of by the staff.Additional patient info from medwatch form received on 13oct2021: patient race is white.Additional information was received via email on 25oct2021 from [name]: alert date was (b)(6) 2021.Type of intervention: a new gelseal cap was used to complete the case.Patient status: no patient injury.
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 non-conformances that could have contributed to the reported event.Based on the description of the event, it is likely that the reported event was caused by improper placement a sleeve that was inserted too close to the smoke evacuation port.It is possible that the sleeve near the smoke evacuation port separated the gel when the sleeve was manipulated, resulting in the leakage reported.Per the instructions for use (ifu), the sleeves should be inserted "at least 1.5cm from the outside perimeter and the insufflation/smoke evacuation ports, in the desired working location." this event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch #(b)(4).

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12704473
• Report Number: 2027111-2021-00691
• Device Sequence Number: 1467761
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)240113(30)01(10)1406123
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 01/13/2024
• Device Model Number: CNGL3
• Device Catalogue Number: 101474188
• Device Lot Number: 1406123
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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: ROBOT
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White