MAUDE Adverse Event Report: APPLIED MEDICAL CA090, DIRECT DRIVE LCA 3/BX; FZP

Model Number CA090

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

The incident device 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.This report is a follow-up to maude report mw# 5042481.

Event Description

"applied medical direct drive, 10mm clip applier stuck closed during the first firing and would not reopen.Clip applier was not used on the patient and handed off the field." intervention - "replacement of defective device." patient status- "fine, this issue was discovered prior to patient use.".

Manufacturer Narrative

This report is to follow up with medwatch# mw5042481.On march 18, 2016, applied medical issued a voluntary class ii recall of the ca090 direct drive clip applier due to increased customer feedback indicating inconsistent clip application, which has the potential to lead to unoccluded vessels.An internal corrective action request has been initiated to conduct a thorough investigation and implement appropriate corrective actions.Fda has issued recall number z-1621-2016 for this recall.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 a supplemental report will be submitted to the fda.

• Brand Name: CA090, DIRECT DRIVE LCA 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5004949
• MDR Text Key: 23111400
• Report Number: 2027111-2015-00544
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 04/28/2015,08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/11/2018
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1240610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Event Location: Hospital
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1621-2016
• Patient Sequence Number: 1