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	02/11/2019
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: unk.Medwatch # (b)(4).The grasper jaws were tight, did not open and close properly.They were taken off the field and replaced with new device without event.There was no harm to the patient.Date of event: (b)(6) 2019.Additional information received via email on 06may2019 from risk management coordinator: date of event (b)(6) 2019 same as stated on medwatch report.Information not provided for the questions at what point during the procedure did the device become difficult to actuate.Information not provided for the question was it difficult to actuate upon initial use.Patient status: there was no harm to the patient.Type of intervention: they were taken off the field and replaced with new device without event.
Additional 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 confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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: unk.Medwatch #0504240000-2019-8015 the grasper jaws were tight, did not open and close properly.They were taken off the field and replaced with new device without event.There was no harm to the patient.Date of event feb 2019.Additional information received via email on 06may2019 from risk management coordinator: date of event 2/11/19 same as stated on med watch report.Information not provided for the questions at what point during the procedure did the device become difficult to actuate.Information not provided for the question was it difficult to actuate upon initial use.Patient status: there was no harm to the patient.Type of intervention: they were taken off the field and replaced with new device without event.

• 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: 8654483
• Report Number: 2027111-2019-00458
• Device Sequence Number: 19404647
• Product Code: NWV
• UDI-Device Identifier: 00607915116866
• UDI-Public: (01)00607915116866(17)211206(30)01(10)1343486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 12/06/2021
• Device Model Number: C4120
• Device Catalogue Number: 101472471
• Device Lot Number: 1343486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1