MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX LAPAROSCOPIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: nissen fundoplication.Event description: the device was used for grasping the stomach during the stomach mobilization.As soon as the device grasped the stomach there was injury and bleeding of the stomach which was caused, according to the surgeon's opinion, by the traumatic latis pads.There was not any clinical impact to the patient other than bleeding, which was immediately controlled by the surgeon, by stitching the trauma.A device of another manufacturer was used to continue the surgical operation.Additional information received from applied medical representative via email on 20feb26: the correct lot nr.Is 1563295.Additional information received from applied medical representative via email on 27feb26: the bleeding of the stomach lining occurred as a result of using the forceps on the stomach.They stitched up the stomach and continued the surgery.The patient¿s condition is fine.No other product was involved.The incident occurred immediately after the forceps grasped the stomach wall.Rips, tears or frays weren't observed on the pad before grasping.Intervention: a device of another manufacturer was used to continue the surgical operation patient status: the patient¿s condition is fine.There was injury and bleeding of the stomach.There was not any clinical impact to the patient other than bleeding, which was immediately controlled by the surgeon, by stitching the trauma.

• Brand Name: EPIX LAPAROSCOPIC GRASPER
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 24565310
• Report Number: 2027111-2026-00433
• Device Sequence Number: 15542413
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: C4130
• Device Catalogue Number: 101476261
• Device Lot Number: 1563295
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 08/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown