MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic cystectomy event description: the handle was attempting to be opened but the jaws were not moving.The reposable grasper was being screwed on normally and then failed to open and operate.Rep was present in the theatre.Another handle was opened and was screwed onto the direct drive grasper and again it wouldn't work.Clinical impact: no, it did not go near the patient.26.07.2024 received clarification that the c4120 was tried on a second handle to determine what was faulty and it turned out to be the c4120.There is only one faulty device and only one device to be returned.Intervention: another form of grasper was used.Patient status: ni.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as there were no visible nonconformances and the unit passed all functional testing.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic cystectomy event description: the handle was attempting to be opened but the jaws were not moving.The reposable grasper was being screwed on normally and then failed to open and operate.Rep was present in the theatre.Another handle was opened and was screwed onto the direct drive grasper and again it wouldn't work.Clinical impact: no, it did not go near the patient.(b)(6) 2024 received clarification that the c4120 was tried on a second handle to determine what was faulty and it turned out to be the c4120.There is only one faulty device and only one device to be returned.Intervention: another form of grasper was used.Patient status: (b)(6).

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• 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: 20036558
• Report Number: 2027111-2024-00790
• Device Sequence Number: 20476395
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)261109(30)01(10)1508133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: C4120
• Device Catalogue Number: 101476259
• Device Lot Number: 1508133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: DIRECT DRIVE HANDLE.
• Patient Sex: Unknown