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

Model Number	C4120
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: adhesiolysis.During the case the surgeon found the atrax to be very clunky when closing and opening the jaw.This sticking or rigidity was not the reusable handle as a second atrax was opened and there was no issue with the second item.Patient status: patient did not incur injury.Type of intervention: opened new product.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the reported event of rough actuation.Based on the condition of the returned unit, it is likely that the reported event of rough actuation was caused by the rivet being too tight which occurred during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: adhesiolysis.During the case the surgeon found the atrax to be very clunky when closing and opening the jaw.This sticking or rigidity was not the reusable handle as a second atrax was opened and there was no issue with the second item patient status: patient did not incur injury.Type of intervention: opened new product.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Common Device Name: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8397327
• Report Number: 2027111-2019-00378
• Device Sequence Number: 16835566
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)211011(30)01(10)1338953
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1338953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1