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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 FER LIGATOR, HEMORRHOIDAL

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COOK IRELAND LTD SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE FER LIGATOR, HEMORRHOIDAL Back to Search Results
Catalog Number HMBL-4-TRI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
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 (cook endoscopy, winston salem nc). One thousand patients underwent colonoscopy with simultaneous three-quadrant internal hemorrhoid ligation over the study period. 18 (1. 8 percent) required elective completion surgical hemorrhoidectomy for persistent symptoms.
 
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Brand NameSHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
Type of DeviceFER LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
MDR Report Key10089408
MDR Text Key192259680
Report Number3001845648-2020-00315
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2020 Patient Sequence Number: 1
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