DORNIER LITHOTRIPTER SII
Received Nov 15, 2013 · Event occurred Oct 22, 2013
Report 1037955-2013-00022 · MDR key 3522516
Device
Generic name
Doli Sii
Manufacturer
Dornier Medtech Systems, GmbhModel number
DOLI SIICatalog number
DOLI SII
Product problems
- Use of Device Problem
Patient
Not reported
- Head Injury
- Laceration(s)
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS A SERVICE CONTRACT WITH DMTS AND AT THE LAST SERVICING IN (B)(4) 2013, THE FOOT SECTION WAS FUNCTIONING PROPERLY. WE CONCLUDE THAT THE ISSUE WAS NOT CAUSED BY A DESIGN FLAW, BUT WAS A RESULT OF THE FOOT SECTION FALLING TO THE FLOOR SOMETIME BEFORE THIS INCIDENT AND SUFFERING A BEND THAT WAS OVERLOOKED BY THE CUSTOMER. THE PT REQUIRED SUTURES TO THE HEAD LACERATION AND IS RECOVERING. DMTS FIELD SERVICE ENGINEER INSTRUCTED CUSTOMER TO EXCHANGE THE BENT LEVER BEFORE NEXT TREATMENT. (B)(4).
Description of Event or Problem
AFTER TREATMENT, THE PT ATTEMPTED TO STEP OFF OF THE STRETCHER, THE FOOT SECTION LOOSENED AND THE PT FELL ON HIS HEAD, RECEIVING A LACERATION. EVENT TOOK PLACE IN (B)(6).