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

Model Number	CNGL3
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
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
Procedure performed: endoscopic nipple-sparing mastectomy event description: the device was used to perform a bilateral endoscopic nipple sparing mastectomy.During the procedure, the surgeon noticed damage to the skin edges, lesion-like abrasions, after removing the device, particularly in the second breast.An open dissection was conducted prior to the placement of the gelpoint mini.During this dissection, the surgeon utilized a metal retractor and a monopolar pen for dissection.It seems that the surgeons may have rolled over the alexis.Additionally, there was significant manipulation of the device, with movement up and down during dissection.The incision skin edges were damaged.The surgeon trimmed the edges of the skin before suturing the incision.Intervention: the surgeon trimmed the edges of the skin before suturing the incision.Patient status: yes, the incision skin edges were damaged.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the damage to the skin was provided.Visual inspection confirmed the complainant¿s experience of skin abrasions.Based on the event description and the provided photo, it is possible that the damage to the skin on the edges of the incision was caused by another device.However, the exact root cause of the injury is unknown.This event was initially reported based on the description of the event.However, based on further examination of the event description and the provided photo, applied medical determined that this event is not reportable as it is unlikely to lead to death or serious deterioration in the state of health.According to a review done by a subject matter expert.
Event or Problem Description
Procedure performed: endoscopic nipple-sparing mastectomy.Event description: the device was used to perform a bilateral endoscopic nipple sparing mastectomy.During the procedure, the surgeon noticed damage to the skin edges, lesion-like abrasions, after removing the device, particularly in the second breast.An open dissection was conducted prior to the placement of the gelpoint mini.During this dissection, the surgeon utilized a metal retractor and a monopolar pen for dissection.It seems that the surgeons may have rolled over the alexis.Additionally, there was significant manipulation of the device, with movement up and down during dissection.The incision skin edges were damaged.The surgeon trimmed the edges of the skin before suturing the incision.Information received by company rep.Via e-mail on 11apr2024: lot no 1506426.Incision size - 3,5-4cm.Yes the surgeon sweep tissue around the inner ring before rolling down the alexis.No damage to the tissue.Intervention: the surgeon trimmed the edges of the skin before suturing the incision.Patient status: yes, the incision skin edges were damaged.

• 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: 19098712
• Report Number: 2027111-2024-00523
• Device Sequence Number: 7736717
• 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): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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: FOR OPEN DISSECTION AND HARMONIC; FOR THE ENDOSCOPIC DISSECTION.; METAL RETRACTORS, MONOPOLAR PEN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown