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 Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The event unit is not anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: laparoscopic cholecystectomy.I was recently informed by a member of staff about problems experienced by two of our surgeons with the clip applier and they are refusing to use the product as of now.I am awaiting a report from both about the nature of the problem.Information provided by applied medical representative via email 12jul21: i have heard that [name] have had a number of patients coming back with a leak where they had used our clip applier.Based on what i have heard from the team members and [surgeon name removed], the clips wouldn¿t close fully.They opened a couple of clip applier for a case and experienced the same with both of them.Unfortunately, they haven¿t kept the products for us to collect.[surgeon name removed] has had one patient coming back and have had an email from [name] regarding one more patient with potential leak.Telephone conversation with applied medical representative 12jul21: confirmed awaiting further information from theatres team lead, but at least 3 likely/reported events have occurred, with at least 2 patients returning for prolonged care with potential re-operation.Patient status: patient returning to care due to leak.Type of intervention: ni.

Event Description

Name of procedure being performed: laparoscopic cholecystectomy.I was recently informed by a member of staff about problems experienced by two of our surgeons with the clip applier and they are refusing to use the product as of now.I am awaiting a report from both about the nature of the problem.Information provided by applied medical representative via email 12jul21: i have heard that [name] have had a number of patients coming back with a leak where they had used our clip applier.Based on what i have heard from the team members and [surgeon name removed], the clips wouldn't close fully.They opened a couple of clip applier for a case and experienced the same with both of them.Unfortunately, they haven't kept the products for us to collect.[surgeon name removed] has had one patient coming back and have had an email from [name] regarding one more patient with potential leak.Telephone conversation with applied medical representative 12jul21: confirmed awaiting further information from theatres team lead, but at least 3 likely/reported events have occurred, with at least 2 patients returning for prolonged care with potential re-operation.Patient status: patient returning to care due to leak.Type of intervention: ni.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.In the absence of the event unit, applied medical is unable to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

• 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: 12230058
• MDR Text Key: 264695924
• Report Number: 2027111-2021-00585
• 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: 09/01/2021

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: 101474072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization