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

Ra has received the event device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Procedure performed: cholecystectomy when loading the clips the surgeon felt that they didn't load like usual.When he tried to close them, the clips didn't close properly.Patient status: n/i.

Manufacturer Narrative

Investigation summary: the event unit was returned to applied medical for evaluation, along with several clips.Testing was performed on the event unit, which confirmed the complainant¿s experience of clips not closing properly.The feeder, a metal component located in the shaft, was measured and was found to be out of specification.Based on the condition of the returned unit and clips, it is likely that the reported event was caused by the feeder that was found to be out of specification upon receipt.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented process and inspection enhancements intended to further minimize the potential for this type of event to occur.The event unit was manufactured prior to implementation of the process and inspection enhancements.

Event Description

Procedure performed: cholecystectomy.When loading the clips the surgeon felt that they didn't load like usual.When he tried to close them, the clips didn't close properly.Patient status: no patient injury.

• 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: 8231662
• MDR Text Key: 132532831
• Report Number: 2027111-2019-00313
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210823(30)01(10)1334677
• 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: 03/21/2019

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: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1334677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1