PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS
Received Dec 22, 2023 · Event occurred Oct 18, 2023
Report 3005334138-2023-00586 · MDR key 18386928
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
St. Jude MedicalModel number
408299Catalog number
408299
Lot number
9942475
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H2, H3 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AS SUPPORTED BY THE RECEIVING INSPECTION RESULTS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED MECHANICAL ISSUE WITH THE FORCEPS AND SUBSEQUENT CANCELLATION REMAINS UNKNOWN.
Additional Manufacturer Narrative
UDI RELATED DATA QUALITY UPDATES ONLY. ADDITIONAL INFORMATION: D4, G6, H2, H6, H11.
Description of Event or Problem
DURING THE PROCEDURE, THE BIOPSY FORCEPS DID NOT OPEN AND CLOSE CONSISTENTLY AND THE PROCEDURE WAS CANCELLED.