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

Model Number CA500

Device Problem Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

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.This report is to follow up with (b)(4).Customer verified this incident was the same medwatch report received.

Event Description

"device shaft has a bend in it.Did not feel it was safe to use on the patient." patient status: device did not touch patient.Medwatch: "the epix universal clip applier would not fire.(two devices failed to operate as intended prior to the beginning of the case.)".

Manufacturer Narrative

Additional information was requested from the customer and provided.This report is to follow up with medwatch# (b)(4).Complainant verified this is the same event.The complainant returned four units, of which two were sterile and never opened.Upon visual inspection of the units, engineering confirmed the dents on the shaft of the devices.The root cause was likely a result of improperly inserting or removing the device from the tray packaging.As designed, the shaft may dent if the device is inserted or removed without proper support of the device handle because the cover tube is thin and can be damaged if not handled carefully.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly process.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 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.(b)(4).

• 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: 5112609
• MDR Text Key: 27102464
• Report Number: 2027111-2015-00691
• 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: 08/25/2015,12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/19/2018
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1246690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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