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

Model Number C4130

Device Problem Mechanical Jam (2983)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: lap cholecystectomy event description: grasper was being used to remove the gall bladder.Surgeon heard a crack when closing the handle and the grasper locked up.Surgeon grabbed a second grasper and the jaws would not close all the way.The third grasper worked and was used to complete the case.Account manager was onsite and confirmed the findings of the surgeon for the first two graspers.No patient injury.Product is available for return.Additional information provided by [name] on 28feb2024 via email: i spoke with the customer again last night and she informed me that the incident occurred on monday 2/26, not yesterday.Thank you for you assistance.Please let me know if there is anything else i can assist with.Additional information provided by [name] on 28feb2024 via email: the jaws did not detach or break off.No materials were lost in the patient.The surgeon was grasping the gallbladder when he heard a snap sound come from the handle.He was able to release the gallbladder at which point a second grasper was opened.The second grasper locked up without tissue in the jaws and was removed.Case was completed using a third grasper.They had one grasper of the same lot as the defective two in their sterile core which we pulled and set aside with the two defective graspers.Patient status: no patient injury.Intervention: the case was completed with a new one.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 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: 19084022
• MDR Text Key: 340684239
• Report Number: 2027111-2024-00508
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)260925(30)01(10)1505316
• 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
• Report Date: 04/10/2024

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
• Device Catalogue Number: 101476261
• Device Lot Number: 1505316
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 09/26/2023
• 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