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

Model Number CA500

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

The incident device anticipated to return.A follow-up report will be provided 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.

Event Description

Lap cholecystectomy: "surgeon went to ligate a bleeding vessel using our 5mm clip applier and handle jammed.Clips could not pre load.Handle stiff." patient status unknown.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering was unable to actuate the device.The unit was disassembled for further evaluation.A significant amount of tissue debris was found within the shaft of the device.The root cause of the customer's experience of handle jamming and improper clip loading is likely the tissue debris found within the shaft.This excessive amount of debris would increase the amount of friction between internal components of the device leading to improper clip loading or instrument jamming.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.Applied medical has reviewed the details surrounding the incident and related products.Applied medical appreciates your feedback and will continue to improve the form, function, and ease of use of its products.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 Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5151714
• MDR Text Key: 28691555
• Report Number: 2027111-2015-00723
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/27/2018
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1247687
• Other Device ID Number: 00607915125318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• 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