MalfunctionFBO
INNER SHEATH ONLY
Received Jan 29, 2020 · Event occurred Oct 28, 2019
Report 9610617-2020-00012 · MDR key 9645089
Device
Product problems
- Material Fragmentation
Patient
68 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PER THE CUSTOMER, THE ITEM WILL NOT BE RETURNED FOR EVALUATION AT THIS TIME.
Description of Event or Problem
PER MEDWATCH REPORT, #MW5091908, RECEIVED ON1/6/2020, DURING A BILATERAL LITHOTRIPSY WITH LEFT URETERAL STENT PLACEMENT PROCEDURE, THE PHYSICIAN NOTICED THE GRAY TIP WAS FRAGMENTED DURING USE. HE FOUND 2 PIECES WHICH WERE RETRIEVED FROM THE PATIENT. THE INSTRUMENT WAS EXCHANGED OUT AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. THEY USED FLUOROSCOPY TO ENSURE NO ADDITIONAL PIECES WERE LEFT INSIDE THE PATIENT.