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

Model Number	CA090
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date occurred in (b)(6) 2014, no specific date was noted.Another possible lot number was mentioned, lot # 1213264.The udi, manufacturing/expiration dates are listed below.The product code and 510(k) code is the same.Manufacturing date: 01/27/2014 expiration date: 01/26/2017 udi: (b)(4).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- "4 events reported with 4 different clip appl, 2 different lots.Not reported specific malfunction associated to prod.Lots reported are 1213391 and 1213264 ( please refer to cer porretta 3,4).The surg reported no firing of clip and no complete closure/ wrong closure of the clip after firing.Intervention was completed with a different bland clip applier.Not possible to retire the samples for inspection because the event was reported to italian ministry of health, so products have to remain available for ministry examination." patient status: good.

• 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: 6395597
• Report Number: 2027111-2017-01577
• Device Sequence Number: 19016965
• Product Code: FZP
• UDI-Device Identifier: 00607915117306
• UDI-Public: (01)00607915117306(17)170204(30)01(10)1213391
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K011236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: Other
• Device Expiration Date: 02/04/2017
• Device Model Number: CA090
• Device Catalogue Number: 100975401
• Device Lot Number: 1213391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2014
• Initial Report FDA Received Date: 03/10/2017
• 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: NEW CLIP APPLIER FROM DIFFERENT BRAND; XCEL ETHICON TROCAR DILATING TIP