MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; LAPAROSCOPIC ACCESSORS, GYNECOLOGICAL

Model Number C4130

Device Problem Material Fragmentation (1261)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.This report is to follow up on medwatch report # mw5147000.

Event Description

Procedure performed: ni.Event description: complaint created based off medwatch.Report # mw5147000.During the procedure there was a foreign body seen in the patient that came from the green grasper, as per dr.(b)(6).A part of the green grasper has damage on it.Green grasper was inspected for any other damages.A 2 view x-ray was offered to dr.(b)(6) and he declined stating that no patient harm was done and it was a small piece that probably would not be seen on x-ray.Charge nurse (b)(6) and manager (b)(6) were notified and talked with the surgeon and case proceeded as scheduled.Product is not returning.Patient status: no patient harm was done.Intervention: case proceeded as scheduled.

Event Description

Procedure performed: ni event description: complaint created based off medwatch.Report # mw5147000 during the procedure there was a foreign body seen in the patient that came from the green grasper, as per dr.(b)(6).A part of the green grasper has damage on it.Green grasper was inspected for any other damages.A 2 view x-ray was offered to dr.(b)(6) and he declined stating that no patient harm was done and it was a small piece that probably would not be seen on x-ray.Charge nurse (b)(6) and manager (b)(6) were notified and talked with the surgeon and case proceeded as scheduled.Product is not returning.Patient status: no patient harm was done intervention: case proceeded as scheduled.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting fom this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORS, GYNECOLOGICAL
• 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: 18127554
• MDR Text Key: 329559868
• Report Number: 2027111-2023-00743
• Device Sequence Number: 1
• Product Code: NWV
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care 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: C4130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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