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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) FIBER-URETERORENOSCOPE URETEROSCOPE, PRODUCT CODE: FGB

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RICHARD WOLF GMBH (GERMANY) FIBER-URETERORENOSCOPE URETEROSCOPE, PRODUCT CODE: FGB Back to Search Results
Model Number 7325.071
Device Problems No Display/Image (1183); Material Integrity Problem (2978); Optical Problem (3001)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Investigation is currently in process. Rwmic and rw (b)(4) considers this report open for missing information and investigation report.
 
Event Description
Richard wolf medical instrument corporation was informed by facility that during a procedure the screen goes dark. Device complaint report answers are provided below: product 7325. 071 will be returned for investigation. The device was being used on a patient when the issue occurred. There was no injury of illness to the patient when the issue occurred. The delay in the procedure put the patient at risk. A similar back-up device was not available for use. The scheduled procedure was completed. Rwmic provided complaint information to the manufacturer rw (b)(4) on (b)(6) 2018. Manufacturer's report number is included in this report.
 
Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information. Missing information: user facility was contacted 3 times in an effort to collect patient information and user information. As of 07/26/2018, rwmic has not received a response. Ifu includes a caution for limited strength. "excessive force will cause damage, impair the function, and therefore endanger the patient. Immediately before and after each use, check products for damage, loose parts, and completion. Do not use the products if they are damaged or incomplete, or have loose parts". Ifu includes a warning for "danger of injury if the auxillary instrument is not visible through the scope. Inadvertent tissue damage as well as damage to the distal end of the fiberscope and to instruments parts are possible" ifu includes a caution for image quality, "increased risk potential is the image is blurred!. Danger of injuring the patient. Stop the intervention for safety reasons if the image is blurred. Check the image quality of the fiberscope before use". Ifu includes checks and functional checks. Functional checks include manual leakage test immediately after use or each time before reprocessing. Rwmic considers this complaint and mdr closed. Follow-up reports will be sent to fda as required.
 
Event Description
Follow-up report #1. User facility returned the device to rwmic on 04/19/2018, rwmic completed the investigation on 06/27/2018. Investigation summary is below: product appearance is used. The complaint condition was not verified. Investigator did report: the distal hose as cut. The distal hose leaks. The ocular leaks. Master bond is cracked. Hard deflection. Equipment used: camera setup and leak tester. (b)(4) was repaired, the complete shaft was replaced.
 
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Brand NameFIBER-URETERORENOSCOPE
Type of DeviceURETEROSCOPE, PRODUCT CODE: FGB
Manufacturer (Section D)
RICHARD WOLF GMBH (GERMANY)
registration number 9611102
32 pforzheimer street
knittlingen, 75438
GM 75438
MDR Report Key7476544
MDR Text Key107458308
Report Number9611102-2018-00008
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04055207013694
UDI-Public04055207013694
Combination Product (y/n)N
PMA/PMN Number
K980401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/26/2018,04/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7325.071
Device Catalogue Number7325.071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2018
Distributor Facility Aware Date04/07/2018
Device Age6 YR
Event Location Other
Date Report to Manufacturer04/19/2018
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/01/2018 Patient Sequence Number: 1
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