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	01/21/2025
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: hiatus hernia repair.Event description: grasping tissue and bowel during hiatus hernia repair, no different to any other case.Surgeon regularly uses 2x atrax graspers in every hiatus hernia repair and has never had an issue.Surgeon moved the camera and noticed that the grasper was not grasping as usual.When he moved the camera, he noticed the blue latis pad in the corner of the screen.Upon checking the grasper, the pad had fallen off and into the patient's abdominal cavity, of which he retrieved.There was no clinical impact to the patient as a result of the event as latis pad was found and retrieved from patient.Surgeon retrieved latis pad from patient and reported via hospital reporting (risk man) and advised all relevant personnel as per hospital policy.Intervention: latis pad from grasper detached from main shaft and was removed by surgeon.Patient status: stable.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the pad was fully dislodged from the jaw.Based on the condition of the returned unit, it is possible that the reported event was caused by adhesive failure at the latis to adhesive surface interface.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: hiatus hernia repair.Event description: grasping tissue and bowel during hiatus hernia repair, no different to any other case.Surgeon regularly uses 2x atrax graspers in every hiatus hernia repair and has never had an issue.Surgeon moved the camera and noticed that the grasper was not grasping as usual.When he moved the camera, he noticed the blue latis pad in the corner of the screen.Upon checking the grasper, the pad had fallen off and into the patient's abdominal cavity, of which he retrieved.There was no clinical impact to the patient as a result of the event as latis pad was found and retrieved from patient.Surgeon retrieved latis pad from patient and reported via hospital reporting (risk man) and advised all relevant personnel as per hospital policy.Intervention: latis pad from grasper detached from main shaft and was removed by surgeon.Patient status: stable.

• 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: 21318216
• Report Number: 2027111-2025-00342
• Device Sequence Number: 12742063
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 1525804
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANOTHER ATRAX GRASPER.; DEBAKEY BOWEL GRASPER.; [COMPETITOR] ENERGY DEVICE.
• Patient Sex: Unknown