FDA Adverse Event
Summary report: N
SIX WIRE LITHOTRIPTOR BASKET, 30 MM LENGTH, 2.6 MM DIAMETER
MDR report key: 154703
·
Received February 10, 1998
Report
- Report Number
- 9680809-1998-90001
- Date Received
- February 10, 1998
- Date of Event
- February 2, 1998
- Manufacturer
- GIP MEDIZINTECHNIK GMBH
- Product Code
- LQC
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
"DURING AN ERCP PROCEDURE A STONE WAS FOUND IN A PTS COMMON BILE DUCT. AFTER THE STONE WAS CAPTURED WITHIN THE BASKET AND THE LITHOTRIPTOR HANDLE WAS CRANKED IN AN ATTEMPT TO CURSH THE STONE, THE LITHOTRIPTOR WIRE SNAPPED. WHEN THE METAL SPIRAL WAS WITHDRAWN FROM THE DUODENOSCOPE, A TWELVE TO EIGHTEEN INCH LENGTH OF FRAYED WIRE WAS LEFT PROTRUDING FROM THE ENDOSCOPE'S CHANNEL INLET. THE WIRE HAD SNAPPED AND WAS COMPLETELY SEVERED AT APPROXIMATELY 73 INCHES FROM DISTAL END. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO FREE THE STONE FROM THE BASKET. HOWEVER, WHEN THIS WAS UNSUCCESSFUL THE PT HAD TO HAVE OPEN SURGERY TO REMOVE THE WIREBASKET AS WELL AS SEVERAL STONES RETAINED IN THE GALL BLADDER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIX WIRE LITHOTRIPTOR BASKET, 30 MM LENGTH, 2.6 MM DIAMETER | SIX WIRE LITHOTRIPTOR BASKET, 30 MM LENGTH, 2.6 MM DIAMETER | LQC | GIP MEDIZINTECHNIK GMBH | * | 96111871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |