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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap chole."dr was performing a lap chole and used the ca500 to ligate the cystic duct and cystic artery.Once the cystic artery and cystic duct were dissected, dr.Used the ca500 to ligate.She pre-loaded each clip prior to firing on the vessel.A few of the clips did not completely close.Once she cut between the clips the clips that had not closed completely fell off the vessel." photo available.Additional information received via email from account manager, on tuesday, 26mar2019: "the clips were fully loaded into the jaws prior to actuation.The trigger was squeezed plastic to plastic.The surgeon fully skeletonized the vessel prior to using the clip applier with graspers.The clip applier was not used to skeletonize.The apex didn¿t close.There are no patient injuries.The surgeon used the horizon clips to secure the vessels post malfunction as a few the clips slid off the vessel once the vessel was cut.There were no concomitant devices used at the time of malfunction.I have requested a no-charge po and will send over as soon as i receive it." additional information received via email from implementation specialist, on wednesday, 17apr2019: "he informed me that the product was thrown away.Please let me know if i can do anything else." patient status: there are no patient injuries.

Event Description

Procedure performed: lap chole "dr was performing a lap chole and used the ca500 to ligate the cystic duct and cystic artery.Once the cystic artery and cystic duct were dissected, dr.Used the ca500 to ligate.She pre-loaded each clip prior to firing on the vessel.A few of the clips did not completely close.Once she cut between the clips the clips that had not closed completely fell off the vessel." photo available additional information received via email from account manager, on tuesday, 26mar2019: "the clips were fully loaded into the jaws prior to actuation.The trigger was squeezed plastic to plastic.The surgeon fully skeletonized the vessel prior to using the clip applier with graspers.The clip applier was not used to skeletonize.The apex didn¿t close.There are no patient injuries.The surgeon used the horizon clips to secure the vessels post malfunction as a few the clips slid off the vessel once the vessel was cut.There were no concomitant devices used at the time of malfunction.I have requested a no-charge po and will send over as soon as i receive it." additional information received via email from implementation specialist, on wednesday, 17apr2019 "he informed me that the product was thrown away.Please let me now if i can do anything else." patient status: there are no patient injuries.

Manufacturer Narrative

Investigative summary: the event unit was not returned to applied medical for evaluation, and the lot number was not provided.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 continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

• 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
• MDR Report Key: 8533767
• MDR Text Key: 145794851
• Report Number: 2027111-2019-00431
• Device Sequence Number: 1
• Product Code: FZP
• 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: 07/01/2019

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 Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 07/01/2019
• Patient Sequence Number: 1