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

Model Number	7
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Lap chole - "the staff opened a clip applier and attempted to use it in the patient, it only had three clips in it which were attempted to be used in the patient.Upon query to the staff nurse michael informs that they needed to open another device in order to finish the procedure." patient status - unknown, patient status unknown.

• Brand Name: CA090, DIRECT DRIVE LCA 3/BX
• Common Device Name: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6391436
• Report Number: 2027111-2017-01564
• Device Sequence Number: 19145374
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)180706(30)01(10)1250211
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 7
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2018
• Device Model Number: 7
• Device Catalogue Number: 7
• Device Lot Number: 1250211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2016
• Initial Report FDA Received Date: 03/09/2017
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1621-2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 'ANOTHER CLIP APPLIER WAS OPENED TO FINISH THE PRO