MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES DIRECT DRIVE REPOSABLE GRASPERS; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4120
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lavh.Event description: a piece of the grasper fell outside of the patient.The device was not able to grasp.The piece that fell was accounted for during the procedure.They were trying to grasp uterine tissue.Additional information obtained from hospital representative via email on 09jun2025: the grasper was being used to grasp the uterus and the hinge became loose.Nothing broke off or fell into the patient, the device just would not grasp.It was removed from the patient and off the field with all pieces intact.When inspecting off the field, a piece fell out from the hinge area.It is not visible in the picture.It is more of a piece of metal that fell from the inside of the hinge while we were inspecting it.Intervention: the grasper was removed from the field and a new grasper was opened.Patient status: no adverse event or injury.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lavh event description: a piece of the grasper fell outside of the patient.The device was not able to grasp.The piece that fell was accounted for during the procedure.They were trying to grasp uterine tissue.Additional information obtained from hospital representative via email on (b)(6) 2025: the grasper was being used to grasp the uterus and the hinge became loose.Nothing broke off or fell into the patient; the device just would not grasp.It was removed from the patient and off the field with all pieces intact.When inspecting off the field, a piece fell out from the hinge area.It is not visible in the picture.It is more of a piece of metal that fell from the inside of the hinge while we were inspecting it.Intervention: the grasper was removed from the field and a new grasper was opened.Patient status: no adverse event or injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed complainant¿s experience of the fractured jaw.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: DIRECT DRIVE REPOSABLE GRASPERS
• 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: 22898298
• Report Number: 2027111-2025-00715
• Device Sequence Number: 21056980
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 1519141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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