FDA Adverse Event
Other
Summary report: N
DORMIA STONE DISLODGER
MDR report key: 43758
·
Received October 16, 1996
Report
- Report Number
- 9610711-1996-00001
- Event Type
- Other
- Date Received
- October 16, 1996
- Date of Event
- August 20, 1996
- Report Date
- October 15, 1996
- Manufacturer
- PORGES, S.A.
- Product Code
- FFL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGEON ATTEMPTED REMOVAL OF 2X4 RT KIDNEY STONE WITH PRODUCT. THERE WAS NO PROBLEM INSERTING THE PRODUCT. WIRE BASKET WITH CAPTURED STONE BECAME LODGED IN THE URETERAL MUCOSA, DEVICE UNABLE TO BE REMOVED. PT WAS "RETURNED" TO SURGERY ON 8/22 FOR CYSTOTOMY, URETEROTOMY. SURGEON'S NOTES INDICATE THAT THE STONE HAD TRANSVERSELY CROSSED THE LOWER SEGMENT AND WAS ABLE TO BE EXTRACTED. STONE WAS TOO LARGE FOR THE URETER TO ALLOW IT TO PASS BECAUSE OF ITS FLEXIBILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DORMIA STONE DISLODGER | STONE BASKET | FFL | PORGES, S.A. | DOR 114 | 910917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R | SURGERY |