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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW CYSTOSCOPE 5° 9.5/11.5FR WL 116MM RIGID

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RICHARD WOLF GMBH PANOVIEW CYSTOSCOPE 5° 9.5/11.5FR WL 116MM RIGID Back to Search Results
Model Number 8626431
Device Problems Material Fragmentation (1261); Blocked Connection (2888)
Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative
Rwmic has requested additional and missing information from the user facility and manufacturer. Rwmic considers this case open at this time and will submit a follow up report upon receipt of additional information as appropriate.
 
Event Description
On april 20, 2020, rwmic received the report mw5094069. In the report, the initial reporter described the following event occurred during a procedure. During the cystoscopy, it was noted that the open-ended 5-french ureteral catheter was being sheared by the scope when the catheter was being withdrawn. Two small shaving were in the bladder as a result of this. The fragments from the 5-french ureteral catheter were identified and removed in their entirety.
 
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Brand NamePANOVIEW
Type of DeviceCYSTOSCOPE 5° 9.5/11.5FR WL 116MM RIGID
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
heiko seider-biedermann
pforzheimer street 32
knittlingen, 75438
GM   75438
MDR Report Key10247467
MDR Text Key198164244
Report Number1418479-2020-00011
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type other
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/08/2020,04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8626431
Device Catalogue Number8626.431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2020
Distributor Facility Aware Date04/20/2020
Event Location Hospital
Date Report to Manufacturer07/08/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/08/2020 Patient Sequence Number: 1
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