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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC SALIVARY STONE EXTRACTOR BASKET SSEB GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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COOK INC SALIVARY STONE EXTRACTOR BASKET SSEB GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number G23798
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2020
Event Type  Malfunction  
Manufacturer Narrative

This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

It was reported that a salivary stone extractor basket was unable to open/close properly as the device's handle was broken. The surgeon was placing the device in the "working channel of scope" during a "sialendoscopy/sialolithiasis" procedure. It was discovered that the basket would not open as the physician was attempting to grasp a stone. The scope was removed "via the working channel" and a new device was used to successfully complete the procedure. The physician and resident were instructed on how to use the device and the device was tested before use. No adverse effects to the patient have been reported.

 
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Brand NameSALIVARY STONE EXTRACTOR BASKET SSEB
Type of DeviceGCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10554447
MDR Text Key207568145
Report Number1820334-2020-01715
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG23798
Device Catalogue NumberSSEB-1.7-115-8
Device LOT Number9639977
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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