MAUDE Adverse Event Report: APPLIED MEDICAL CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; FZP

Model Number CA500

Device Problem Retraction Problem (1536)

Patient Problem Injury (2348)

Event Date 12/08/2014

Event Type  Injury  

Manufacturer Narrative

This report is to follow up with maude report# (b)(4).No product is being returned for evaluation but lot number is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.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- "surgeon performing laparoscopic cholecystectomy.While attempting to clip the bile duct, the clip applier clamped down, but would not release.Surgeon had to modify his procedure (laparoscopic to open chole) and removed the bile duct and suture the hepatic duct to prevent a bile leak.A drain was placed to monitor for a bile leak, which did occur.This required a mrcp, then an ercp with stent placement which resolved the lead.Patient had an increase in hospital days and extra procedures due to the malfunction of the clip applier.Patient was not an any other medications at the time." type of intervention- "a laparoscopic procedure was changed to open and a larger piece of the common bile duct was removed." patient status - "patient developed a leak that required repair at the incision site under were the clip applier was stuck shut.".

Manufacturer Narrative

(b)(4).Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.  all clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.As a part of this process, each unit is inspected for clip feeding during manufacturing prior to packaging.This report is to follow up with maude report# mw5039734.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 4988420
• MDR Text Key: 22432848
• Report Number: 2027111-2015-00534
• Device Sequence Number: 1
• Product Code: FZP
• 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
• Type of Report: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/22/2017
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1231562
• Other Device ID Number: 00607915125318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention