PERCUTANEOUS NEPHROSTOMY DILATOR
Received Jun 19, 2026
Report 9610711-2026-00197 · MDR key 25562672
Device
Product problems
- Device Markings/Labelling Problem
Patient
NA · Unknown
- Kidney injury
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, CONTAINED A SHAFT THAT WAS¿CONTRARY TO EXPECTATION¿TOO SHORT. ACCORDING TO THE CATALOG AND TECHNICAL DATA SHEET, A 21 CM LONG SPLIT SHAFT SHOULD HAVE BEEN INCLUDED. THE CUSTOMER STATES THAT, IN THE PAST, THEY HAD CONSISTENTLY RECEIVED THE SHORT VERSION OF THE RBC008. BECAUSE A 21 CM SHAFT WAS SUDDENLY INCLUDED, THE SENIOR PHYSICIAN INADVERTENTLY INJURED THE PATIENT'S KIDNEY (THOUGH LIKELY WITHOUT LASTING CONSEQUENCES). FURTHERMORE, THE CUSTOMER IS CONFUSED BY THE CHARRIÈRE SIZE "9" PRINTED ON THE LUER HUB, AS IT OUGHT TO BE AN 8 CH.