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

Model Number C4120

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: laparoscopic toupet fundoplication and paraesophageal hernia repair the rep was not present during the case.During the case the latis mesh of the grasper pad frayed.About 50% of the of the mesh was detached from the pad.This was noted about 20 minutes into the case.The grasper was used the grasp esophageal and stomach tissue.The surgeon noted that the case was not a difficult one and that they did not use excessive force when using the graspers.The complaint graspers were used to complete the case.No patient injury.Product is available for return.Additional information received via email on 13nov2020 from [name], applied medical (b)(4)."no mesh fell into the patient." product is available for return.Intervention: finished case with grasper.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the latis of the grasper pad was frayed.The latis weld was inspected and there were no signs of a manufacturing defect.Based on the condition of the returned unit, the reported event was caused by a broken latis weld, which occurred while the device was being used.Applied medical is unable to determine the root cause of the broken latis weld based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: laparoscopic toupet fundoplication and paraesophageal hernia repair.The rep was not present during the case.During the case the latis mesh of the grasper pad frayed.About 50% of the of the mesh was detached from the pad.This was noted about 20 minutes into the case.The grasper was used the grasp esophageal and stomach tissue.The surgeon noted that the case was not a difficult one and that they did not use excessive force when using the graspers.The complaint graspers were used to complete the case.No patient injury.Additional information received via email on 13nov2020: "i have attached 2 photos.No mesh fell into the patient." product is available for return.Intervention: finished case with grasper.Procedure performed: no patient injury.

• 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
• MDR Report Key: 10840230
• MDR Text Key: 247664435
• Report Number: 2027111-2020-00621
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1