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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA VISION SENSOR URETERORENOSCOPE

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RICHARD WOLF GMBH COBRA VISION SENSOR URETERORENOSCOPE Back to Search Results
Model Number 7356071
Device Problem Blocked Connection (2888)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Rwmic considers this case open. A follow up will be provided upon completion of the device evaluation and/or receipt of additional information.
 
Event Description
On july 24, 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): during a procedure, "200 trac tip" fiber was advanced through both working channels and it got hung up and would not advance all the way. Will the device be returned? yes. Was the device being used during a procedure when the issue occurred? yes. Specifically, was the device being used on a patient when the issue occurred? yes. Was there any injury or illness to patient or other personnel due to issue? unknown. Did the issue cause a delay in the procedure being performed that put the patient at risk? yes. Was there a similar back-up device available for use? yes. Was the scheduled procedure completed? yes. How was the patient anesthetized? general.
 
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Brand NameCOBRA VISION
Type of DeviceSENSOR URETERORENOSCOPE
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, 75438
GM 75438
Manufacturer Contact
oliver ehrlich
pforzheimer street 32
knittlingen, 75438
GM   75438
MDR Report Key8927182
MDR Text Key200389642
Report Number1418479-2019-00041
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/23/2019,07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
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 Manufacturer08/21/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2019
Distributor Facility Aware Date07/24/2019
Event Location Hospital
Date Report to Manufacturer08/23/2019
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? No
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: 08/23/2019 Patient Sequence Number: 1
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