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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 Hemorrhage/Bleeding (1888); Blood Loss (2597)
Event Date 09/11/2020
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Patient ended up with serious bleeding initial correspondence from rep on the (b)(4). Rep received a complaint today (12 october 2020) regarding the shortshot saeed hemorrhoidal multi-band ligator with triview anoscope. The complaint came from (b)(6), but this hospital did not use the product. A nurse at (b)(6) passed on this feedback to me from (b)(6) hospital who did use the product. The feedback is that the (b)(6) site have had post procedural issues following use of the shortshot. One patient ended up with serious bleeding and another required hospital stay afterwards. Description- shortshot saeed hemorrhoidal multi-band ligator with triview anoscope. Initial complaint came from (b)(6), but this hospital did not use the product. Cook rep was advised by a nurse from this establishment. Product used by (b)(6) hospital. (b)(6) site have had post procedural issues following use of the shortshot. Two issues with two separate patient. This file is capturing the patient that suffered bleeding following the use of shortshot, an additional file was created to capture the patient who required hospital stay.
 
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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
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key10813803
MDR Text Key218505640
Report Number3001845648-2020-00836
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K060623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberHMBL-4-TRI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/11/2020
Event Location Hospital
Date Manufacturer Received10/12/2020
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: 11/09/2020 Patient Sequence Number: 1
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