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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
Catalog Number SSEB-1.7-115-8
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Occupation: supply chain coordinator. 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 the basket of a salivary stone extractor basket sseb "would open but wouldn't go down the scope". The ngauge basket was opened to check its functionality. The basket wasn't fully closing and was unable to fit down the working channel of the sialendoscope. Another ngauge basket was opened and found to by fully functional, so this was used to complete the procedure.

 
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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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9727575
MDR Text Key184738350
Report Number1820334-2020-00404
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK120468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSSEB-1.7-115-8
Device LOT Number9623156
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2019
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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