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

Model Number CA500

Device Problems Bent (1059); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

Gastric bypass - "clips were coming out malformed due to bent shaft." patient status - "ok.".

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 noted a dent along the shaft.Engineering actuated the device and experienced incomplete clip closure.The bent shaft may have contributed to the improper clip loading.Although the root cause of the damaged shaft cannot be determined, the dent on the shaft likely happened 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.This document represents our final report.

• 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 ; 949713-823
• MDR Report Key: 4836478
• MDR Text Key: 5941608
• Report Number: 2027111-2015-00356
• 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
• Report Date: 08/16/2015

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
• Device Operator: Other
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1243903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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