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: lap cholecystectomy.The surgeon was performing a lap cholecystectomy and was using ca500 to place a clip on the cystic artery.Ca500 was operated correctly and the clip did not fully close even though the handle was activated "plastic to plastic".Answers to the script questions are attached and below: the clip was fully loaded in the jaws.The trigger was activated plastic to plastic.The vessel was fully skeletonized prior to placing clip on the cystic artery.The clip did not close at the apex (basically looked like a cholangiogram clip).Patient status: no patient injury or illness occured associated with the complaint event.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of incomplete clip closure could not be replicated or confirmed.The event unit met current specifications and there were no visible non-conformances.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the user's clip application technique.The instructions for use (ifu) instructs the user to "ensure that each clip is secure and completely positioned around the tissue being ligated" and "verify that the ligation site is free of obstructions or other clips before firing." applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is researching possible enhancements intended to further minimize the potential for this type of event to occur.

Event Description

Procedure performed: lap cholecystectomy.The surgeon was performing a lap cholecystectomy and was using ca500 to place a clip on the cystic artery.Ca500 was operated correctly and the clip did not fully close even though the handle was activated "plastic to plastic".Answers to the script questions are attached and below: - the clip was fully loaded in the jaws; - the trigger was activated plastic to plastic; - the vessel was fully skeletonized prior to placing clip on the cystic artery; - the clip did not close at the apex (basically looked like a cholangiogram clip).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: 8238265
• MDR Text Key: 133963944
• Report Number: 2027111-2019-00317
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)210819(30)01(01)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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1