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

Model Number	C4120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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: lap bso.Event description: prior to reporting, internal hospital document filled by nurse states: blue grasper tip came off in patient during laparoscopic salpingo-oopherectomy and was luckily seen and found immediately from pcf on 25jun2025: grasper was being used as per usual, and the operating team noticed the blue "latis" pad had fallen off the grasper tips.Additional information was provided by [name], ama territory manager via email on 26-jun-2025.The lot number of the complaint device was confirmed as 1538058.The territory manager believes it would have been ordered from [location].Intervention: device was replaced.Patient status: unaffected.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that one of the pads latis braiding had unraveled and the pad had detached from the jaw.Based on the condition of the returned unit, it is likely that the torn latis material occurred as a result of the use of the grasper.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: lap bso.Event description: prior to reporting, internal hospital document filled by nurse states: blue grasper tip came off in patient during laparoscopic salpingo-oopherectomy and was luckily seen and found immediately.From pcf on 25jun2025: grasper was being used as per usual, and the operating team noticed the blue "latis" pad had fallen off the grasper tips.Additional information was provided by [name], ama territory manager via email on 26-jun-2025.The lot number of the complaint device was confirmed as 1538058.The territory manager believes it would have been ordered from [location].Intervention: device was replaced.Patient status: unaffected.

• 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: 22384425
• Report Number: 2027111-2025-00622
• Device Sequence Number: 8663555
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 1538058
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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