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

Model Number CA090

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

This report is to follow up with medwatch# mw5061301.(b)(4) has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent 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.

Event Description

Laparoscopic cholecystectomy - "whenever the applied medical direct drive disposable laparoscopic clip applier would be compressed on the tissue, a clip would be discharged and crimped.As the handle would be returned to the start position, a second uncrimped clip would be expelled into the abdomen.All attempts were made to recover the uncrimped staples that were identified as the issue with this stapler." type of intervention: significant irrigation to attempt to remove all expelled, uncrimped staples.Patient status - stable.

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.This report is to follow up with medwatch# mw5061301.

Event Description

Laparoscopic cholecystectomy: "whenever the applied medical direct drive disposable laparoscopic clip applier would be compressed on the tissue, a clip would be discharged and crimped.As the handle would be returned to the start position, a second uncrimped clip would be expelled into the abdomen.All attempts were made to recover the uncrimped staples that were identified as the issue with this stapler." type of intervention: significant irrigation to attempt to remove all expelled, uncrimped staples.Patient status: stable.

• 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: 5692983
• MDR Text Key: 46365650
• Report Number: 2027111-2016-00427
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)181104(30)01(10)1258730
• 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: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2018
• Device Model Number: CA090
• Device Catalogue Number: 101416101
• Device Lot Number: 1258730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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
• Patient Outcome(s): Required Intervention