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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 Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Ser 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. User then complaint the rest of the same product on hand. Sales rep. Mentioned through phone that user facility store the product in operation room during covid-19 quarantine and keep doing operating room disinfection regularly. This pr captures those lot# which was not used in procedure but only tested for functionality, as well as those was not tested as unwanted by user facility.
 
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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 Key10121290
MDR Text Key241371718
Report Number3001845648-2020-00337
Device Sequence Number1
Product Code FER
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2020
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 Date05/08/2020
Event Location Hospital
Date Manufacturer Received05/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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