MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4119, 32CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4119

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.

Event Description

"the grasper was being used in a adrenalectomy.Staff noticed blue pieces from mesh in the patient which they retrieved." patient status: patient is ok.

Manufacturer Narrative

The event unit was returned for evaluation.Upon inspection, engineering observed that the pad and jaw of the event unit were damaged.Testing confirmed that the damage observed to the event unit was caused by ultrasonic instrumentation.The root cause of the damage is use error, as the device is not designed to withstand direct contact from ultrasonic instrumentation.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.

• Brand Name: C4119, 32CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 6115089
• MDR Text Key: 60427596
• Report Number: 2027111-2016-00777
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116859
• UDI-Public: (01)00607915116859(17)190706(30)01(10)1274388
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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: Other
• Device Expiration Date: 07/06/2019
• Device Model Number: C4119
• Device Catalogue Number: 100863901
• Device Lot Number: 1274388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1