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

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit observed that the channel support assembly (csa) and feeder, metal components in the shaft, were damaged.Testing was performed on the returned unit, confirming the complainant¿s experience of improper clip loading and clip scissoring.During functional testing, the clips fired were either improperly closed or scissored.Based on the condition of the returned unit, it is likely that the reported event was caused by the damaged csa and feeder, which likely resulted from the components being caught within the jaws and further damaged when the device was inserted through the trocar.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Type of procedure: laparoscopic pppd (pylorus-preserving pancreatoduodenectomy) event description: when loading a clip, it was not properly position.There was no health change.The surgery was replaced with a new device.Image of device is attached.Additional information received via email (b)(6) 2022 from [name], amk operation supervisor.The issue was observed when loading the first clip.Five clips were dispensed in total.Trocar used was a cff03.No pressure was applied to the trigger while moving through the trocar.The clip was loaded into the jaws prior to the device's insertion/removal through the trocar.The actuation was completed by fully squeezing the trigger and allowing the device to rest.Customer also reports that a clip was manually removed as a loaded clip, leaving the feeder exposed.After this, the device was actuated and reset.Additional information received on (b)(6) y2022 via email from [name], amk operation supervisor.Actual batch is 1421907 after confirming with dealer.Product is available for return.Lot traces to account (b)(4).Additional information received via email on (b)(6) 2022 from [name], complaint evaluation engineer.The unit from complaint 2022-000521 was evaluated today, (b)(6) 22.A clip scissored during the [test method].Type of intervention: the surgery was replaced with a new device.Patient status: there was no prolem with the patient.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14704673
• MDR Text Key: 294141328
• Report Number: 2027111-2022-00634
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240628(30)01(10)1421907
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1421907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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
• Treatment: CFF03