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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH URETEROSCOPES

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RICHARD WOLF GMBH URETEROSCOPES Back to Search Results
Model Number 7356071
Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Rwmic has requested additional information from the user facility and the manufacturer for missing information; device evaluation results are expected and rwmic will provide a follow up report upon receipt of such information as appropriate. Rwmic considers this case open.
 
Event Description
Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified of an event that occurred at the hospital, on an unspecified date, during a patient procedure. The picture allegedly froze up while scope was in the ureter. A back up device was available and the procedure was completed. There was a delay in therapy that put the patient at risk but there was no adverse outcome reported as a consequence of this event.
 
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Brand NameURETEROSCOPES
Type of DeviceURETEROSCOPES
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, gm 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, gm 75438
GM 75438
Manufacturer Contact
oliver ehrlich
pforzheimer street 32
knittlingen, gm 75438
GM   75438
MDR Report Key7866793
MDR Text Key120708482
Report Number1418479-2018-00015
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04055207054864
UDI-Public04055207054864
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/12/2019,08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7356071
Device Catalogue Number7356071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/12/2019
Distributor Facility Aware Date10/31/2018
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer03/12/2019
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1
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