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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. RESECTOSCOPE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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RICHARD WOLF MEDICAL INSTRUMENTS CORP. RESECTOSCOPE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL Back to Search Results
Catalog Number 4653.1313
Device Problems Break (1069); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2016
Event Type  malfunction  
Event Description
While performing a hysteroscopic polyp resection, the cutting loop sparked and the screen went blue.After this happened, the surgeon removed the resectoscope and noticed the cutting loop was broken.The cutting loop was taken off the field and the surgeon proceeded with the procedure using a rollerball.No harm to the patient.
 
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Brand Name
RESECTOSCOPE
Type of Device
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods parkway
vernon hills IL 60061
MDR Report Key5966216
MDR Text Key55232603
Report Number5966216
Device Sequence Number1
Product Code FAS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date02/01/2020
Device Catalogue Number4653.1313
Device Lot Number4500161523
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2016
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer08/29/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
POSSIBLY THE RESECTOSCOPE.
Patient Age72 YR
Patient Weight70
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