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

Model Number	CNGL3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the investigation.
Event or Problem Description
Procedure performed: hysterectomy, laparoscopic total (lth) with salpingo-oopherectomy of uterus greater than 250g.Event description: a piece of the wound retractor measuring 3mm that was torn off by the grasper.The device worked as it should.The staff described medical doctor grabbing the bag right under the green ring with a grasper and a piece of the bag tore off and dropped into the abdomen.Additional information obtained from hospital representative via email on 14nov2024 the patient was discharged.No patient injury or illness was associated with the complaint event.The product particulated.The particulated part fell into the patient.All of the material was retrieved.Additional information obtained from hospital representative via email on 18nov2024 the retractor was used for the remainder of the surgery.A search was completed to locate the missing piece.Intervention: the retractor was used for the remainder of the surgery.A search was completed to locate the missing piece.Patient status: discharged.
Event or Problem Description
Procedure performed: hysterectomy, laparoscopic total (lth) with salpingo-oopherectomy of uterus greater than 250g.Event description: this complaint is associated with (b)(4).A piece of the wound retractor measuring 3mm that was torn off by the grasper.The device worked as it should.The staff described medical doctor grabbing the bag right under the green ring with a grasper and a piece of the bag tore off and dropped into the abdomen.Additional information obtained from hospital representative via email on 14nov2024, the patient was discharged.No patient injury or illness was associated with the complaint event.The product particulated.The particulated part fell into the patient.All of the material was retrieved.Additional information obtained from hospital representative via email on 18nov2024, the retractor was used for the remainder of the surgery.A search was completed to locate the missing piece.Additional information obtained from user report in maude (report number (b)(4)).The event date is 02oct2024.Additional information obtained from hospital representative via email on 08jan2025 the item comes direct from the vendor.Intervention: the retractor was used for the remainder of the surgery.A search was completed to locate the missing piece.Patient status: discharged.
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 possible that a sharp object or instrument came into contact with the sheath during the procedure and created a hole or tear in the sheath that may have further propagated due to the stress experienced by the sheath.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This is a follow-up report to (b)(4).Correction: e4.

• Brand Name: GELPOINT® MINI ADVANCED 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20758868
• Report Number: 2027111-2024-00923
• Device Sequence Number: 8587785
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNGL3
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 05/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPER; WOUND RETRACTOR
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 66 KG