MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4121, 45CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4121

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Type of procedure: ni.Event description: hospital: [hospital].Product: 45cm grasper."robotic case.Blue pads (reporter assumes both blue pads of the grasper) detached and fell into the patient.The surgeon was able to retrieve the pads." products available for return.Patient status: no patient injury or illness occurred associated with the complaint event.Intervention: ni.

Manufacturer Narrative

The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of pad detachment.Based on the condition of the returned unit, it is likely that the pad detachment occurred due to adhesive failure.It is also likely that this occurred during usage.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Type of procedure: ni.Event description: hospital: [hospital].Product: 45cm grasper."robotic case.Blue pads (reporter assumes both blue pads of the grasper) detached and fell into the patient.The surgeon was able to retrieve the pads." products available for return.Patient status: no patient injury or illness occurred associated with the complaint event.Intervention: ni.

• Brand Name: C4121, 45CM GRASPER REPOS CART, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18895138
• MDR Text Key: 337560189
• Report Number: 2027111-2024-00435
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116873
• UDI-Public: (01)00607915116873(17)260725(30)01(10)1496447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: C4121
• Device Catalogue Number: 101472473
• Device Lot Number: 1496447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1