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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED INSTINCT; HEMOSTATIC METAL CLIP FOR THE GI TRACT
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COOK INCORPORATED INSTINCT; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number G58010
Device Problems Defective Component (2292); Activation Problem (4042)
Patient Problem Insufficient Information (4580)
Event Date 08/05/2021
Event Type  malfunction  
Event Description
Cook hemoclip would not deploy as designed.Product was defective.Per operative report: procedures performed: esophagogastroduodenoscopy with otsc removal.Colonoscopy with hot snare polypectomy, cold snare polypectomy, and hemoclip deployment in the left lateral position, the digital rectal examination revealed no mass.The olympus hd video colonoscope was inserted through the anus and advanced to cecum.The position was confirmed by identification of the appendiceal orifice, ileocecal valve, and intubation of the terminal ileum.Device and packaging saved.
 
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Brand Name
INSTINCT
Type of Device
HEMOSTATIC METAL CLIP FOR THE GI TRACT
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key12376928
MDR Text Key268482790
Report Number12376928
Device Sequence Number1
Product Code PKL
UDI-Device Identifier00827002580107
UDI-Public(01)00827002580107(17)240419(10)W4462063
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG58010
Device Catalogue NumberINSC-P-7-230-S
Device Lot NumberW4462063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2021
Event Location Hospital
Date Report to Manufacturer08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18980 DA
Patient Weight68
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