MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4120

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

Procedure performed: lap endometriosis.Event description: it is unsure how the device was being used when the event occurred.After about an hour of general use of grasping and retracting, the contact pad became detached, and had to be retrieved from inside the patient.No harm though.There was no clinical impact to the patient as a result of the event.It is unsure how the user resolved the situation.It is unsure if there were other instruments used when the complaint event occurred.Additional information received from [name] via email on 31 may 2023: i¿ve attached some photos of the faulty c4120 from [user facility].They must have thrown it out.Intervention: unsure.Patient status: ok.

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: lap endometriosis event description: it is unsure how the device was being used when the event occurred.After about an hour of general use of grasping and retracting, the contact pad became detached, and had to be retrieved from inside the patient.No harm though.There was no clinical impact to the patient as a result of the event.It is unsure how the user resolved the situation.It is unsure if there were other instruments used when the complaint event occurred.Additional information received from [name] via email on 31 may 2023: i¿ve attached some photos of the faulty c4120 from [user facility].They must have thrown it out.Intervention: unsure.Patient status: ok.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the customer¿s experience of pad detachment.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 from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C4120, 38CM 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: 17066337
• MDR Text Key: 317656920
• Report Number: 2027111-2023-00475
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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: C4120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1