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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 N/A
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  Malfunction  
Manufacturer Narrative

Occupation: senior buyer. 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 ngage salivary stone extractor basket used during a sialendoscopy procedure was difficult to close. During use, the device wouldn't close enough to grab the stone so another had to be opened to continue with the procedure. As reported, the patient did not experience any adverse effects due to this occurrence.

 
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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 Key9251152
MDR Text Key174307167
Report Number1820334-2019-02718
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberSSEB-1.7-115-8
Device LOT Number9005800
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2018
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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