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 Injury (2348)

Event Date 02/04/2019

Event Type  Injury  

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: cholecystectomy.The surgeon asked me, that he have with 3 young men's by the gallbladder revisions because the clips don't keep on the artery and cysticus.Additional information received from sales representative via email on 08feb2019: the clips were no longer on the cystic duct and cystic artery during the revision-surgery.The doctor wants to monitor it, because there was nothing unusual during lap.Sigmoid resections the customer has been trained on the correct use of the device and has assured me of this again.It was squeezed plastic to plastic ¿ as taught during the training.Skeletonization is done in this hospital with a dissector, clip appliers are only used for vessels.The customer thinks that these incidents could be explained because of the young, athletic patients.Patient status: home.

Event Description

Procedure performed: cholecystectomy.The surgeon ask me, that he have with 3 young men's by the gallbladder revisions because the clips don't keep on the artery and cysticus.Additional information received from sales representative via email on 08feb2019: the clips were no longer on the cystic duct and cystic artery during the revision-surgery.The doctor wants to monitor it, because there was nothing unusual during lap.Sigmoid resections.1.The customer has been trained on the correct use of the device and has assured me of this again.2.It was squeezed plastic to plastic as taught during the training.3.Skeletonization is done in this hospital with a dissector, clip appliers are only used for vessels.The customer thinks that these incidents could be explained because of the young, athletic patients.Patient status: home.

Manufacturer Narrative

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 has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.

• 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: 8384187
• MDR Text Key: 137662106
• Report Number: 2027111-2019-00374
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization