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

Model Number	C4130
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of adhesion at the front tip as multiple frays were observed on the latis pads.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by frays identified on the latis pad.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit and further examination of the event description, applied medical determined that this event is reportable.This report represents the initial and follow-up report.
Event or Problem Description
Procedure performed: robotic lar.Event description: complaint 1 of 2: (b)(4), complaint 2 of 2: (b)(4).[hospital] after using this instrument for a period of time, the front tip will become adhesive to tissues.Changing to another instrument for use will still result in adhesion at the front tip, until the third grasper is used to complete the surgery.There is no impact to patient.User replace with new grasper to complete this surgery.There is no other instruments to affect this event.Product is available for return.Additional information received on 15aug2023 via email from [distributor]: intestine tissue was being grasped at the time of the incident.Intervention: user replace with new grasper to complete this surgery.Patient status: fine.

• 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: 20931951
• Report Number: 2027111-2024-00960
• Device Sequence Number: 18214328
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/13/2024

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 Expiration Date: 10/10/2025
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: 1465123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Patient Sex: Unknown