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

Model Number CA500

Device Problems Loss of or Failure to Bond (1068); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

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: hand assisted sigmoid colectomy standard lap technique.Limited information is available.Ca500 misfired twice during procedure.First clip scissored and the second was a tear drop shape.Clip applier was retained and is being sent back for evaluation.Additional information received via email on (b)(6) 2018 from applied medical account manager.The case was completed laparoscopically.The patient status is stable.The procedure was done using standard lap techniques.The clip applier was being used to clip a bleeding vessel when the experience occurred.No pressure was applied to the trigger while moving through the trocar.A clip was not loaded into the jaws prior to the device¿s insertion/removal through the trocar.It should not fit thru a 5 mm trocar if the clip is exposed.A clip was not manually removed as a loaded clip, leaving the feeder exposed.The scissored was clip removed from the patient.The trigger was squeezed "plastic to plastic".There are photos or video of the procedure available.Additional information was received via mail from the fda medwatch mw5081930 on 03jan2019.Lot #1329323 clip applier.Event type: malfunction event date: (b)(6) 2018."pt in surgery for a laparoscopic had assist sigmoid colectomy.The applied medical epix universal clip applier, lot#1329323, misfired two times (scissored/criss crossed) while being used by the surgeon.New competitor device clip applier opened to finish the case.No harm to the pt per the surgeon." patient status: stable.

Manufacturer Narrative

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: hand assisted sigmoid colectomy standard lap technique limited information is available.Ca500 misfired twice during procedure.First clip scissored and the second was a tear drop shape.Clip applier was retained and is being sent back for evaluation.Additional information received via email on 13dec2018 from applied medical account manager.The case was completed laparoscopically.The patient status is stable.The procedure was done using standard lap techniques.The clip applier was being used to clip a bleeding vessel when the experience occurred.No pressure was applied to the trigger while moving through the trocar.A clip was not loaded into the jaws prior to the device¿s insertion/removal through the trocar.It should not fit thru a 5 mm trocar if the clip is exposed.A clip was not manually removed as a loaded clip, leaving the feeder exposed.The scissored was clip removed from the patient.The trigger was squeezed "plastic to plastic".There are photos or video of the procedure available.Additional information was received via mail from the fda medwatch5081930 on 03jan2019.Lot #1329323 clip applier.Event type: malfunction event date: 03dec2018."pt in surgery for a laparoscopic had assist sigmoid colectomy.The applied medical epix universal clip applier, lot#1329323, misfired two times (scissored/criss crossed) while being used by the surgeon.New competitor device clip applier opened to finish the case.No harm to the pt per the surgeon." patient status: stable.

• 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: 8233470
• MDR Text Key: 133858746
• Report Number: 2027111-2019-00314
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210614(30)01(10)1329323
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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: 06/14/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1329323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1