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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH & CO. HOPKINS II TELESCOPE

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KARL STORZ GMBH & CO. HOPKINS II TELESCOPE Back to Search Results
Model Number 27005BA
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/02/2015
Event Type  Malfunction  
Manufacturer Narrative

The metal on distal end of scope is burnt and melted; a small piece on distal end is broken off. The objective lens & distal end seal are compromised. The distal window is broken on the scope. The wire of the cutting loop melted on one side of the resectoscope & damaged telescope. It is possible settings were too high.

 
Event Description

Allegedly, doctor was performing a transurethral resection of a bladder tumor, when the wire of the cutting loop melted on one side and damaged telescope, and a piece of distal end of scope broke in the patient. The small piece was retrieved. Procedure was completed. There was no report of injury.

 
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Brand NameHOPKINS II TELESCOPE
Type of DeviceTELESCOPE
Manufacturer (Section D)
KARL STORZ GMBH & CO.
tuttlingen
GM
Manufacturer Contact
susie chen
mittelstrasse 8
tuttlingen 
GM  
4242188201
MDR Report Key4987724
MDR Text Key23271814
Report Number9610617-2015-00061
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK943176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number27005BA
Device Catalogue Number27005BA
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/09/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

Patient TREATMENT DATA
Date Received: 07/31/2015 Patient Sequence Number: 1
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