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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
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COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE Back to Search Results
Catalog Number HMBL-4-TRI
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device name: fer ligator, hemorrhoidal.(b)(4).
 
Event Description
According to the journal article: f.Yi et al 2011- "combined colonoscopy and three quadrant hemorrhoidal ligation: 1000 cases." conventional colonoscopy was performed under moderate sedation, followed immediate-ly by synchronous three-quadrant hemorrhoidal ligation, using a triview¿ anoscope and short-shot¿ hemor-rhoidal ligator (another manufacturer).One thousand patients underwent colonoscopy with simultaneous three-quadrant internal hemorrhoid ligation (previously reported) over the study period.18 (1.8 percent) required elective completion surgical hemorrhoidectomy for persistent symptoms (subject of this report).
 
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Brand Name
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10082416
MDR Text Key192149138
Report Number3005580113-2020-00368
Device Sequence Number1
Product Code FHN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/21/2020,05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/29/2020
Event Location Hospital
Date Report to Manufacturer05/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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