FDA Adverse Event
Malfunction
Summary report: N
ANGIO LOCK HEMACLIPS
MDR report key: 23646678
·
Received November 25, 2025
Report
- Report Number
- MW5179411
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- November 20, 2025
- Report Date
- November 20, 2025
- Manufacturer
- MEDLINE INDUSTRIES, LP - NORTHFIELD
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING THE LAP CHOLE CASE, SURGEON WAS USING NEW PRODUCT OF ANGIO LOCK HEMOCLIPS SIZE M/L GREEN PLASTIC; 2 CLIPS CRUMBLED WHILE ATTEMPTING TO PLACE ON CYSTIC BILE DUCT AND SURGEON HAD TO MANUALLY GRAB EACH PLASTIC PIECE OUT. ALL PACKS OF CLIPS WERE FROM THE SAME LOT OF 30053B493.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2137643 | ANGIO LOCK HEMACLIPS | CLIP, IMPLANTABLE | FZP | MEDLINE INDUSTRIES, LP - NORTHFIELD | 30053B493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |