FDA Adverse Event
Malfunction
Summary report: N
DORNIER COMPACT DELTA
MDR report key: 2191339
·
Received July 27, 2011
Report
- Report Number
- 1037955-2011-00013
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 27, 2011
- Manufacturer
- DORNIER MEDTECH SYSTEMS GMBH
- Product Code
- LNS
- PMA / PMN Number
- P840008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS EXAMINED BY ACCOMPLISHING FUNCTIONAL CHECKS ACCORDING TO DEFINED TEST PROCEDURES IN THE SVC GUIDELINES. ALL RESULTS SHOWED THAT THE DEVICE WAS FOUND TO BE IN THE SPECS. IT WAS VERIFIED THAT THE CUSTOMER IS IN POSSESSION OF THE CURRENT OPERATING MANUAL FOR THIS DEVICE WHICH LISTS ALL OF WARNINGS AND CAUTION STATEMENTS REGARDING TREATING KIDNEY STONES. A NEW TRAINING ON THE DEVICE WAS PROPOSED TO THE CUSTOMER. THE PT IS CURRENTLY IN RECOVERING PHASE.
Description of Event or Problem · 1
PT EXPERIENCED COMPLICATIONS AFTER LITHOTRIPSY TREATMENT; KIDNEY HAD TO BE REMOVED. EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DORNIER COMPACT DELTA | LITHOTRIPTER | LNS | DORNIER MEDTECH SYSTEMS GMBH | COMPACT DELTA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |