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

Model Number CA090

Device Problem Expulsion (2933)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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.

Event Description

"many clips were launched at the same time.This cer sample has been collected as one of our recall product according to the raqs team's decision.Customer didn't want to have our feedback.The product will be replaced when ca090 is available again with korean stock.Cer submission has been delayed because korea sales manager changed their account." patient status - unknown.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.On (b)(6) 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.

• 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: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5749460
• MDR Text Key: 48191460
• Report Number: 2027111-2016-00471
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)180427(30)01(10)1243604
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/27/2018
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1243604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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