UROLIFT UL400 DELIVERY DEVICE & IMPLANT
Report
- Report Number
- 3015181082-2025-00064
- Event Type
- Malfunction
- Date Received
- November 10, 2025
- Date of Event
- September 19, 2025
- Report Date
- November 7, 2025
- Manufacturer
- NEOTRACT, INC.
- Product Code
- PEW
- UDI-DI
- 10814932021487
- PMA / PMN Number
- K193269
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED, AND THE FOLLOWING OBSERVATIONS WERE MADE: RECEIVED WITHOUT TRAY, PUSHER NOT DEPLOYED, CUTTER NOT DEPLOYED, NEEDLE TRIGGER EXTENDED, RETRACT LEVER FULLY EXTENDED, LEVER LOCK AND TAPE ENGAGED, URETHRAL ENDPIECE (UE) READY TO DEPLOY, DISTAL TIP UNDAMAGED, UNSHEATHING PAWL NOT ENGAGED WITH SUTURE SPOOL, SUTURE UNBUCKLED, SHUTTLE NOT ENGAGED WITH NEEDLE SPOOL, SUTURE FERRULE IN PLACE, CASE RIGHT UNDAMAGED THE ITEMS LISTED ABOVE ARE INDICATORS OF DEVICE STATUS AND ARE AS EXPECTED FOR A DEVICE THAT FUNCTIONED AS DESIGNED. THE FOLLOWING DISCREPANCIES WERE OBSERVED: NEEDLE DAMAGED: THE NEEDLE IS BROKEN AT THE TIP AND BENT NEAR THE NEEDLE SPOOL. REFER TO DIMENSIONAL INSPECTION FOR ADDITIONAL DETAIL. CAPSULAR TAB (CT) DID NOT UNSHEATHE. THE NEEDLE WAS FOUND TO BE BROKEN AT TWO LOCATIONS. THE NEEDLE TIP WAS FOUND TO BE BROKEN APPROXIMATELY 2.5MM. COMPARISON WITH A REFERENCE NEEDLE SHOWS APPROXIMATELY 2.5MM OF NEEDLE MISSING. THE MISSING NEEDLE MATERIAL WAS NOT RETURNED WITH THE DEVICE. THE NEEDLE IS BROKEN AT 28MM FROM THE TIP. THE BREAK INTERFACE OF THE BROKEN NEEDLE IS IRREGULAR, AND IT IS NOT POSSIBLE TO DETERMINE IF THERE IS ANY MISSING MATERIAL TO REPORT. ANY POSSIBLE MISSING MATERIAL IS ESTIMATED TO BE LESS THAN 1 MM IN LENGTH. THE NEEDLE WAS FOUND TO BE BENT APPROXIMATELY 6.6 MM FROM THE NEEDLE SPOOL. FUNCTIONAL INSPECTION WAS NOT PERFORMED BECAUSE BONE STRIKE IS A DOCUMENTED KNOWN POSSIBLE OUTCOME OF THE UROLIFT PROCEDURE WHICH IS TYPICALLY THE RESULT OF DEVICE POSITIONING OR EXCESSIVE MOVEMENT OF THE DEVICE OR PATIENT ANATOMY. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER REPORT OF "NEEDLE CONTACTED BONE" WAS CONFIRMED. CONFIRMATION IS BASED ON THE INVESTIGATION RESULTS SHOWING THAT THE DEVICE CT DID NOT UNSHEATHE DUE TO BONE STRIKE. THIS IS A KNOWN POSSIBLE OUTCOME OF THE PROCEDURE AND IS NOT INDICATIVE OF A DEVICE MALFUNCTION. THIS INVESTIGATION HAS DETERMINED THAT THE DEVICE ENCOUNTERED THE FOLLOWING FAILURE MODE(S): UL-NEEDLE DAMAGED: NEEDLE DAMAGE OCCURS WHEN THE NEEDLE STRIKES BONE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR UNINTENTIONAL- CANNOT DETERMINE. UL-CT DID NOT UNSHEATHE: THE CT WAS UNABLE TO DEPLOY DUE TO THE DAMAGED NEEDLE INTERFERING WITH CT DEPLOYMENT. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERR-UNINTENTIONAL-CANNOT DETERMINE. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.
IT WAS REPORTED "DURING THE PROCEDURE, DESPITE APPLYING ADEQUATE COMPRESSION, THE NEEDLE CONTACTED BONE. CONSEQUENTLY, THE DEVICE WAS REMOVED, AND THE CASE WAS CONTINUED WITH A NEW DEVICE". THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED "DURING THE PROCEDURE, DESPITE APPLYING ADEQUATE COMPRESSION, THE NEEDLE CONTACTED BONE. CONSEQUENTLY, THE DEVICE WAS REMOVED, AND THE CASE WAS CONTINUED WITH A NEW DEVICE". THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1962665 | UROLIFT UL400 DELIVERY DEVICE & IMPLANT | IMPLANTABLE TRANSPROSTATIC TIS | PEW | NEOTRACT, INC. | 73C2400507 | 10814932021487 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |