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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY KARL STORZ ENDOSCOPY STONE EXTRACTOR, 0.4MM, 4 WIRES

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KARL STORZ ENDOSCOPY KARL STORZ ENDOSCOPY STONE EXTRACTOR, 0.4MM, 4 WIRES Back to Search Results
Model Number 11582M
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Patient Problems Discomfort (2330); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 02/02/2017
Event Type  Injury  
Event Description
During the sialoendoscopy procedure multiple storz stone extractor baskets were used to attempt to extract a stone that was lodged in a salivary gland duct. The baskets (ref #s 11575l, 11575k, 11582m) were all broken at some point during the procedure whether they were opened around the stone or just from simply being opened and closed according to the physician who was performing the procedure. During one of the attempts to extract a stone basket which was opened around the stone broke off from the rest of the device and was left around the stone and lodged in place making it irretrievable. Many attempts were made to retrieve the stone and the basket around the stone, but were unsuccessful. Some of the baskets were left retained inside the salivary gland duct. Overall, 8 baskets were broken in some fashion during the course of this procedure. There were 8 stone extractor baskets used and all 8 failed.
 
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Brand NameKARL STORZ ENDOSCOPY
Type of DeviceSTONE EXTRACTOR, 0.4MM, 4 WIRES
Manufacturer (Section D)
KARL STORZ ENDOSCOPY
tuttingen
GM
MDR Report Key6361332
MDR Text Key68536884
Report Number6361332
Device Sequence Number1
Product Code FFL
UDI-Device Identifier04048551051863
UDI-Public(01)04048551051863(240)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model Number11582M
Device Catalogue Number11582M
Device Lot Number4144020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2017
Distributor Facility Aware Date02/02/2017
Event Location Hospital
Date Report to Manufacturer02/14/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/15/2017 Patient Sequence Number: 1
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