MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION EPIX UNIVERSAL CLIP APPLIER; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Leak/Splash (1354)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

The handle of device was leaking an oily substance onto the surgeon¿s hand and the field.Two of these were opened with the same issue (same lot#).Surgeons¿ gloves were changed, and item removed from field.No harm to patient.Another clip applier was opened (different lot#) without issue.

• Brand Name: EPIX UNIVERSAL CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita, CA 92688
• MDR Report Key: 15751823
• MDR Text Key: 303247651
• Report Number: 15751823
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: CA500
• Device Lot Number: 1459348
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female