MAUDE Adverse Event Report: AMR 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 02/03/2016

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

Laparoscopic gastrectomy - "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 (b)(4) stock.(b)(4) submission has been delayed because (b)(4) sales manager changed their account." patient status - unknown.

Manufacturer Narrative

Updated - the incident device was confirmed and not returned to the manufacturer on october 03, 2016.The event unit was not returned for evaluation.In the absence of the subject device, it can be difficult to determine the root cause.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 preventive 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.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.

• Brand Name: CA090, DIRECT DRIVE LCA 3/BX
• Type of Device: FZP
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5749468
• MDR Text Key: 48193103
• Report Number: 2027111-2016-00474
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)180609(30)01(10)1244386
• 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: 05/26/2016

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: 06/09/2018
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1244386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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