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

Model Number C4120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap bowel resection.A-trac perforated small bowel when surgeon was pulling bowel out of an internal hernia.The tissue was completely necrotic.Surgeon did not have the locking mechanism on, they were simply picking up and moving bowel.Patient status: patient injury did not occur.Type of intervention: unknown.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: lap bowel resection.A-trac perforated small bowel when surgeon was pulling bowel out of an internal hernia.The tissue was completely necrotic.Surgeon did not have the locking mechanism on, they were simply picking up and moving bowel.Patient status: patient injury did not occur.Type of intervention: unknown.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8011929
• MDR Text Key: 125285980
• Report Number: 2027111-2018-00396
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: 10/02/2018
• Initial Date FDA Received: 10/28/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1