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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) BOA VISION FLEXIBLE SENSOR URETERO-RENOSCOPE FLEXIBLE URETERO-RENOSCOPE

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RICHARD WOLF GERMANY (GMBH) BOA VISION FLEXIBLE SENSOR URETERO-RENOSCOPE FLEXIBLE URETERO-RENOSCOPE Back to Search Results
Model Number 7355071
Device Problem Folded (2630)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2016
Event Type  Injury  
Event Description

Richard wolf medical instruments corporation (rwmic) was notified by a company representative that device in question was stuck inside of a patient. Excessive force was needed to remove device from patient. No injury to patient reported. Device in question was returned to rwmic on 05/24/2016 and will be sent to manufacturer on or around 06/01/2016. Facility has been contacted in effort to gather missing information, no response as of 05/25/2016. Rwmic considers this matter closed. However, in the event additional information is received, rwmic will provide manufacturer with information.

 
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Brand NameBOA VISION FLEXIBLE SENSOR URETERO-RENOSCOPE
Type of DeviceFLEXIBLE URETERO-RENOSCOPE
Manufacturer (Section D)
RICHARD WOLF GERMANY (GMBH)
registration #9611102
32 pforzheimer street
knittlingen 75438
GM 75438
MDR Report Key5680009
MDR Text Key45959905
Report Number1418479-2016-00011
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/25/2016,04/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number7355071
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2016
Distributor Facility Aware Date04/27/2016
Device Age1 yr
Event Location AMBULATORY SURGICAL Facility
Date Report TO Manufacturer05/25/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/25/2016 Patient Sequence Number: 1
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