MAUDE Adverse Event Report: APPLIED MEDICAL C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; NWV

Model Number C4130

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2014

Event Type  malfunction  

Manufacturer Narrative

Full udi unknown since no lot number was provided.Investigation summary: the event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot could not be performed as no lot number was provided.  during the manufacturing assembly process, applied medical graspers are functionally tested 100%.Although the root cause of your experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary ensure the performance and safety of our product.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Robotic thorascopy- "silicone pad came off of device.Appeared to have no glue or adhesive on malfunctioned side.Surgeon does not know if pad came off during procedure or before.Surgeon flooded the cavity to make the pad float but never saw it." patient status- "seems to fine.Being discharged today.(b)(6 )2014.".

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5295752
• MDR Text Key: 34074243
• Report Number: 2027111-2015-00896
• Device Sequence Number: 1
• Product Code: NWV
• 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
• Report Date: 12/01/2014

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: C4130
• Device Catalogue Number: 100915401
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00607915110147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1