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

Model Number C4120

Device Problem Difficult to Advance (2920)

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

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow-up report will be sent once the results have been analyzed.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.

Event Description

Gastric bypass - "a-trac grasper experienced resistance when advancing through competitive trocar (covidien) 5mm.Feels as though there was something stuck in the seal.Experienced on each advancement.Patient status - unknown.

Manufacturer Narrative

Investigation summary: the event unit was not returned for evaluation.In the absence of the event unit it is difficult to determine the exact root cause of the incident.Based on the event description, engineering believes that the resistance the customer experienced when advancing and retracting the grasper through a competitor's trocar was due to the smaller cannula inner diameter of the competitor's trocar.Applied medical continuously seeks to improve the form, function and ease of use of its products and as part of this process, will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.

• Brand Name: C4120, 38CM GRASPER REPOS CART, 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: 5670568
• MDR Text Key: 45633290
• Report Number: 2027111-2016-00402
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2016
• 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