FDA Adverse Event Malfunction Summary report: N

DORNIER COMPACT DELTA LITHOTRIPTER

MDR report key: 5361285 · Received January 12, 2016

Report

Report Number: 1037955-2015-00032
Event Type: Malfunction
Date Received: January 12, 2016
Report Date: January 11, 2016
Manufacturer: DORNIER MEDTECH SYSTEMS GMBH
Product Code: LNS
PMA / PMN Number: P840008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

A SERVICE REPORT COMPLETED AND DATED 12/03/15 BY A DMTJ FIELD SERVICE ENGINEER INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. A HEMATOMA IS LISTED AS A POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE COMPACT DELTA OPERATING MANUAL. THE DETAILS CONCERNING INDIVIDUAL PATIENT OUTCOMES INDICATED THAT ALL PATIENTS RECOVERED AND HAD HEALED HEMATOMAS. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. DORNIER MEDTECH AMERICA, INC. (THE REPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012002. INCIDENT OCCURRED IN JAPAN. NOTE: THIS REPORTABLE EVENT ASSIGNED AS MFR REPORT # 1037955-2015-00032 WAS ORIGINALLY SUBMITTED BY MISTAKE AS A DUPLICATED MFR REPORT # 1037955-2015-0033 AND ACKNOWLEDGED RECEIVED BY THE FDA ON JANUARY 11, 2016 09:43:49 PM. THIS REPORT TAKES THE PLACE OF THE DUPLICATED REPORT. THE CORRECT MFR REPORT # 1037955-2015-0033 WAS ACKNOWLEDGED RECEIVED BY THE FDA ON JANUARY 11, 2016 10:35:53 AM.

Description of Event or Problem · 0

A PATIENT HEMATOMA WAS REPORTED AFTER ESWL TREATMENT FOR RENAL OR URETERAL CALCULUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20424	DORNIER COMPACT DELTA LITHOTRIPTER	LITHOTRIPTER	LNS	DORNIER MEDTECH SYSTEMS GMBH	COMPACT DELTA

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Other