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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
Model Number G34063
Device Problems Unintended Movement (3026); Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
When the band was deployed it is meant to shrink down in size but this did not happen.
 
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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 Key10945397
MDR Text Key219514374
Report Number3001845648-2020-00916
Device Sequence Number1
Product Code FER
UDI-Device Identifier00827002340633
UDI-Public(01)00827002340633(17)210424(10)C1728958
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K060623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/24/2021
Device Model NumberG34063
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberC1728958
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2020
Event Location Hospital
Date Manufacturer Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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