MalfunctionFBO
INNER SHEATH ONLY
Received Jan 29, 2020 · Event occurred Dec 18, 2019
Report 9610617-2020-00013 · MDR key 9645088
Device
Product problems
- Material Fragmentation
Patient
56 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, #MW5091907, RECEIVED ON 1/6/2020, DURING A TRANSURETHERAL RESECTION OF THE PROSTATE PROCEDURE, THE PHYSICIAN NOTICED THE GRAY TIP WAS FRAGMENTED. HE FOUND 3 PIECES IN THE PATIENTS BLADDER WHICH WERE RETRIEVED FROM THE PATIENT WITH A GRASPER. 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.