MalfunctionLYK
PERIVU ANGIOSCOPE
Received Jun 7, 2024 · Event occurred Feb 26, 2024
Report 19483789 · MDR key 19483789
Device
Generic name
Angioscope
Manufacturer
Lemaitre Vascular, Inc.Model number
A5000Catalog number
A5000
Lot number
ANG1200
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AFTER PRODUCT WAS REMOVED FROM THE PACKAGING, IT WAS OBSERVED THAT THERE WAS A KINK IN THE TUBING, NEAR THE BLACK HANDLE, AND THE WIRE INSIDE WAS SEVERED. PRODUCT WAS ATTEMPTED TO BE USED BUT DID NOT FUNCTION PROPERLY. MANUFACTURER RESPONSE FOR PERIVU DISPOSABLE ANGIOSCOPE, PERIVU DISPOSABLE ANGIOSCOPE (PER SITE REPORTER). EMAILED TO [REDACTED NAME] FROM [REDACTED NAME]. [REDACTED DATE] MANUFACTURER COMPLAINT FORM SENT TO [REDACTED NAME].