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 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: cholecystectomy.The surgery was performed by attending dr.When dr.Positioned the jaws of the clip applier over the to be clipped tissue, dr.Loaded a clip, positioned it on the appropriate place and actuated the trigger completely.The clip did not close completely and totally blocked during a next try.A new ca500 was used then to finish the surgery.No injury to the patient.As far as we know, reusable trocars were used.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual component inspection found multiple components to be severely damaged, which likely occurred during use.Testing was not performed as the returned unit was unable to fire clips.Therefore, the complainant¿s experience of clips not closing completely could not be replicated or confirmed.Although the exact root cause of the reported event could not be determined.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: cholecystektomie.Die op wurde von oa dr.[name] durchgeführt.Als er mit den branchen des clippers über dem zu clippenden gewebe war, lud er einen clip vor, positionierte diesen an der passenden stelle und drückte dann den abzug des clippes voll durch.Der clip hat sich nicht komplett geschlossen und bei einem weiteren versuch komplett blockiert.Daraufhin wurde ein neuer ca500 zum beenden des eingriffs verwendet.Der patient kam nicht zu schaden.Soweit bekannt wurden wiederverwendbare trokare genommen.The surgery was performed by attending dr.When dr.Positioned the jaws of the clip applier over the to be clipped tissue, dr.Loaded a clip, positioned it on the appropriate place and actuated the trigger completely.The clip did not close completely and totally blocked during a next try.A new ca500 was used then to finish the surgery.As far as we know, reusable trocars were used.Patient status: no injury to the patient.

• 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: 8229719
• MDR Text Key: 132575973
• Report Number: 2027111-2019-00312
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210826(30)01(10)1334678
• 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: 03/07/2019

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: 08/26/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1334678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1