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

Model Number	C4120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering observed that the pad and jaw were damaged, which confirmed the complainant¿s experience.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument that came into contact with the grasper jaw.Based on the damage observed on the pad and jaw, it is likely that heat from the instrument caused the pad and jaw to deform.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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 or Problem Description
Procedure performed: lap high anterior resection.The blue insert breaking away.More information to follow.On (b)(6) 2018 - no more information about event, other than the gel pads on the grasper jaws coming away.The lot no is 1323560.Patient status: patient did not occur injury.Type of intervention: unknown.

• 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: 8511700
• Report Number: 2027111-2019-00421
• Device Sequence Number: 11091622
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)210422(30)01(10)1323560
• 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
• Report Date (Section B): 04/12/2019

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: 04/22/2021
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: 1323560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1