MalfunctionDXC
MEDI LOOP
Received May 15, 2024 · Event occurred Nov 15, 2023
Report 8030107-2024-00002 · MDR key 19317513
Device
Generic name
Vessel Loop
Manufacturer
Degania Silicone LtdModel number
231031280MYCatalog number
231031280MY
Lot number
P2143261
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE VESSEL LOOP WAS USED DURING A PROCEDURE, THEN IT WAS BROKEN AND THE CUSTOMER CLAIMED THAT THE VESSEL LOOP WAS NOT VISIBLE DURING X-RAY, NO PATIENT INJURY AND NO MEDICAL INTERVENTION.
Remedial action
- Other