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

Model Number CA500

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)

Event Date 08/08/2022

Event Type  Injury  

Event Description

On the day of surgery, clip applied during laparoscopic cholecystectomy, using clip applicator, to the cystic artery.At the end of the procedure, the cystic artery was occluded and there was no evidence of active bleeding.The following day patient became hypotensive with a hemoglobin of 4.8.She was taken back to the or emergently for an exploratory laparotomy where it was found the clip was no longer on the cystic artery.

• 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: 15241467
• MDR Text Key: 298087960
• Report Number: 15241467
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: CA500
• Device Lot Number: #1456429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 21535 DA
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic