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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-1.5-115-10
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/27/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
It was reported that when the physician grabbed the stone and started to pull, one of the basket wires broke.No pieces of the device were left in the patient, and there were no injuries.
 
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Brand Name
SALIVARY STONE EXTRACTOR BASKET SSEB
Common Device Name
GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7118045
Report Number1820334-2017-04120
Device Sequence Number19129188
Product Code GCJ
UDI-Device Identifier00827002237971
UDI-Public(01)00827002237971(17)171118(10)5453684
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberSSEB-1.5-115-10
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2017
Initial Report FDA Received Date12/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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