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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap cholley.Surgeon was performing a lap cholley ad said that two clips that were deployed failed to ligate properly.Information was limited but apparently two clips came loose from either cystic duct or artery.Clip applier wasnt kept and was discarded.Patient status: no patient injury or illness occured associated with the complaint event.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Procedure performed: lap cholley.Surgeon was performing a lap cholley ad said that two clips that were deployed failed to ligate properly.Information was limited but apparently two clips came loose from either cystic duct or artery.Clip applier wasnt kept and was discarded.Patient status: no patient injury or illness occured associated with the complaint event.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: FZP
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8255401
• MDR Text Key: 134575859
• Report Number: 2027111-2019-00319
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210819(30)01(10)1334434
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1334434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Patient Sequence Number: 1