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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

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: laparoscopic colon resection event description: the rep was present during the case.The device was used throughout the case.Near the end of the case the surgical team noted that it felt like the grasper was sticking onto the colon.The grasper could still be removed from the colon without extra intervention.No damage was noted to the colon.At the end of the case the grasper was examined and the latis mesh pad appeared to be "unravelling".The case was completed with the complaint device.No patient injury.No product return.Product was disposed of by the facility.Additional information received via email on 28apr2022 from [name], applied medical account manager i: the model number is c4120.No pieces of the pad were torn off.Intervention: the case was completed with the complaint device.Patient status: no patient injury.No damage noted to the colon.

Event Description

Procedure performed: laparoscopic colon resection.Event description: the rep was present during the case.The device was used throughout the case.Near the end of the case the surgical team noted that it felt like the grasper was sticking onto the colon.The grasper could still be removed from the colon without extra intervention.No damage was noted to the colon.At the end of the case the grasper was examined and the latis mesh pad appeared to be "unravelling".The case was completed with the complaint device.No patient injury.No product return.Product was disposed of by the facility.Additional information received via email on 28apr2022 from [name], applied medical account manager i: the model number is c4120.No pieces of the pad were torn off.Intervention: the case was completed with the complaint device.Patient status: no patient injury.No damage noted to the colon.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, which confirmed the lattice was frayed.Based on the description of the event, it is possible that the reported event occurred while the device was being used.However, the exact root cause of the unraveled lattice is unknown.The probability and criticality of the 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14479468
• MDR Text Key: 292499063
• Report Number: 2027111-2022-00605
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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