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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. CYSTOSCOPE, FLEXIBLE, 15 FR

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RICHARD WOLF MEDICAL INSTRUMENTS CORP. CYSTOSCOPE, FLEXIBLE, 15 FR Back to Search Results
Model Number 7305.006
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Foreign Body In Patient (2687)
Event Type  Malfunction  
Manufacturer Narrative

An investigation was completed as the actual device was returned to the (b)(4) facility on 07/02/2015. The brushing that fell into the patient had laser damage completely through, splitting it. The busing was then able to be squeezed smaller than the working channel and fall out of the device (see attached photo). The objective head of device also took a strong laser hit and vertebrae was broken in two places. Above damage indicates user error during the handling of the device. Device was purchased new on (b)(6) 2014. Request for add'l info sent to initial reporter. No response as of 07/24/2015. Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions. (b)(4) considers this matter closed. However, in the event we receive add'l info, we will provide fda w/follow-up info. See scanned page.

 
Event Description

(b)(4) was notified by facility that during a procedure a piece of the device in question broke off into patient. Foreign object was easily retrievable and procedure completed as scheduled w/no injury to patient.

 
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Brand NameCYSTOSCOPE, FLEXIBLE, 15 FR
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills IL 60061
Manufacturer Contact
dawn clark
353 corporate woods pkwy.
vernon hills, IL 60061
8479558016
MDR Report Key4953248
MDR Text Key23023475
Report Number1418479-2015-00022
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 Manufacturer
Source Type USER FACILITY
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 06/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7305.006
Device Catalogue Number7305.006
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/02/2015
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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