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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
Procode: fer ligator, hemorrhoidal. (b)(4).
 
Event Description
Per journal article: f. Yi et al 2011- "combined colonoscopy and three quadrant hemorrhoidal ligation: 1000 cases. " "one thousand patients underwent colonoscopy with simultaneous three-quadrant internal hemorrhoid ligation over the study period. Nine hundred and thirty four patients (93. 4 percent) had complete resolution of their symptoms, and required no further treatment. Sixty six patients (6. 6 percent) required repeat ligation, and 18 (1. 8 percent) required elective completion surgical hemorrhoidectomy for persistent symptoms. No patient required emergency readmission for bleeding or sepsis and no patient required blood transfusion. Four incidental colon carcinomas were identified, and ligation was deferred. No patients required admission for post procedure bleeding. There were no case of pelvic sepsis, and no patients required emergent surgical intervention. ".
 
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Brand NameSHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10079909
MDR Text Key193024449
Report Number3005580113-2020-00365
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/21/2020 Patient Sequence Number: 1
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