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

Model Number CA500

Device Problems Difficult to Remove (1528); Dent in Material (2526)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

Lap chole- "dr.(b)(6) was using the epix universal clip applier on a lap chole and once placed on the duct, he pulled the handle and it would not release.After a while, he was able to get the device removed.He examined it and believe there is a dent on the shaft.They opened up another and the second one was dented on the shaft as well, do they did not use it." patient status- "n/a".

Manufacturer Narrative

Ra 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.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed minor dents along the shaft of the returned unit.The dents along the shaft likely occurred while removing the device from the tray packaging.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.As a part of this process, applied medical is currently investigating packaging enhancements intended to further minimize the potential for this type of incident to occur.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• 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: 4934088
• MDR Text Key: 6034931
• Report Number: 2027111-2015-00489
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/16/2018
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1242807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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