FDA Adverse Event
Other
Summary report: N
*
MDR report key: 51585
·
Received November 21, 1996
Report
- Report Number
- 1018233-1996-00013
- Event Type
- Other
- Date Received
- November 21, 1996
- Product Code
- FFL
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AFTER BASKET BROKE, SHAFT WAS RMVD & GRASPING FORCEPS PLACED THRU PREV. PLACED ENDOSCOPE TO RETRIEVE BASET W/ STONE ENCLOSED. PROCEDURE WAS COMPLETE & SUCCESSFUL. THERE WERE NO FURTHER COMPLICATIONS & NO DAMAGE TO THE PT. ALL UNITS ARE 100% PULL FORCE TESTED IN PROCESS TO ENSURE PRODUCT MEETS SPECIFICATIONS. IN-HOUSE TEST RESULTS OF 5 ADD'L UNITS SHOWED THAT UNITS EXCEEDED PULL FORCE SPECS WHERE SOLDER WAS INADEQUATELY APPLIED. IN-USE DAMAGE TO UNIT MAY BE CONTRIBUTOR TO FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | FFL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |