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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 Patient-Device Incompatibility (2682); Unintended Movement (3026)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
User sucked the hemorrhoids in place and rotated the spool releasing the band, but the band has no elasticity. Band didn't shrink. User changed another same device and checked the function while found out the band didn't shrink neither. See pr298953. User then changed another brand of similar device to complete the procedure. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. ".
 
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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 Key10087885
MDR Text Key192030243
Report Number3001845648-2020-00312
Device Sequence Number1
Product Code FER
UDI-Device Identifier00827002340633
UDI-Public(01)00827002340633(17)200513(10)C1613056
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K060623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/13/2020
Device Model NumberG34063
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberC1613056
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/28/2020
Event Location Hospital
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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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