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

Model Number C4120

Device Problem Material Frayed (1262)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: toupet fundoplication.During the case the jaws of the grasper locked up and were stuck open.The jaws almost came off at the hinge.This occurred in the middle of the case while the grasper was being used on stomach tissue.The device worked fine until this event.The surgeon uses two graspers in this procedure and when this grasper locked up, the surgeon opened up a new grasper to continue the case.No patient injury.Additional information received via email on 07dec2020 from applied medical health system specialist."no piece of the device fell into the patient." no pictures are available of the device.Product is available for return.Intervention: opened up a third set of graspers when the first grasper failed.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering observed that the knob was loose and was able to slide up and down the shaft.The c-ring had dislodged from a slot in the shaft and damage was observed near the slot.The latis of one of the grasper pads was also frayed.The latis weld was inspected and there were no signs of a manufacturing defect.Based on the condition of the returned unit, the jaws of the grasper were stuck open because the c-ring had dislodged from a slot in the shaft.The frayed latis on the grasper pad was caused by a broken latis weld, which occurred while the device was being used.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Jaws that are stuck in the open position is not considered to be a reportable event as it is unlikely to cause or contribute to death or serious injury.This event is reportable due to the frayed latis that was observed on the grasper pad during the evaluation of the returned unit.

Event Description

Procedure performed: toupet fundoplication.During the case the jaws of the grasper locked up and were stuck open.The jaws almost came off at the hinge.This occurred in the middle of the case while the grasper was being used on stomach tissue.The device worked fine until this event.The surgeon uses two graspers in this procedure and when this grasper locked up, the surgeon opened up a new grasper to continue the case.No patient injury.Product is available for return.Additional information received via email on 07dec2020 from applied medical health system specialist."no piece of the device fell into the patient." no pictures are available of the device.Intervention: opened up a third set of graspers when the first grasper failed.Patient status: no patient injury.

• Brand Name: C4120, 38CM LATIS GRASPER 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: 11396727
• MDR Text Key: 266053460
• Report Number: 2027111-2021-00366
• 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: 03/02/2021

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
• Device Catalogue Number: 101473343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1