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

Model Number CA500

Device Problem Failure to Fire (2610)

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

Event Type  malfunction  

Event Description

Procedure performed: unknown.Event description: complaint 1 of 21: (b)(4), complaint 2 of 21: (b)(4), complaint 3 of 21: (b)(4), complaint 4 of 21: (b)(4), complaint 5 of 21: (b)(4), complaint 6 of 21: (b)(4), complaint 7 of 21: (b)(4), complaint 8 of 21: (b)(4), complaint 9 of 21: (b)(4), complaint 10 of 21: (b)(4), complaint 11 of 21: (b)(4), complaint 12 of 21: (b)(4), complaint 13 of 21: (b)(4), complaint 14 of 21: (b)(4), complaint 15 of 21: (b)(4), complaint 16 of 21:(b)(4), complaint 17 of 21: (b)(4), complaint 18 of 21: (b)(4); complaint 19 of 21: (b)(4), complaint 20 of 21: (b)(4), complaint 21 of 21: (b)(4).Customer had several complains before.They totally lost trust and don't want to use the clipper anymore.Since month very often problems, the clipper is just not functional.Information received by applied medical rep via email on 28feb24: no clips made it between the branches.The customer hasn't submitted all complaints, because customers are upset and tired to do that again and again.Information received by applied medical rep via email on 29feb24: there are a lot of complaint not reported, and also never afterwards.Information received by applied medical rep via email on 11mar24: no patient injury happened, there are about 20 not reported cases and all cases regarding to no clip loaded issue.Patient status: no impact to patient.Intervention: unknown.

Manufacturer Narrative

Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint is unknown, however, it is likely to be within the scope of the recall.

• 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 Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19125480
• MDR Text Key: 341374779
• Report Number: 2027111-2024-00560
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027111-01/26/24-001-R
• Patient Sequence Number: 1