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

Model Number 13

Device Problems Misfire (2532); Mechanical Jam (2983)

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

Event Date 02/17/2015

Event Type  malfunction  

Manufacturer Narrative

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 and preventative action (capa) has been initiated to conduct a thorough investigation and implement appropriate corrective actions.Fda has issued recall number z-1621-2016 for this recall.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Lap chole- "doc used clip applier, failed and spit clips.Doctor stated he was tired of the inconsistencies with our clip.Stated for two years he never had an issue until the past few weeks.Problem is they never turned in or requested cer.My counterpart has sent in other cers within the past few days for surgery center these docs do cases at with our clip.Account usage annually is roughly 1000 units.Are requesting an engineer, marketing or two managers for a site business to keep business." patient status - unknown.

• Brand Name: CA090, DIRECT DRIVE LCA 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6366896
• MDR Text Key: 68609724
• Report Number: 2027111-2017-00574
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)171105(30)01(10)1234374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 13
• 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: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2017
• Device Model Number: 13
• Device Catalogue Number: 13
• Device Lot Number: 1234374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Treatment: LAP SET, AND APPLIED TROCARS