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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 Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned to cirl for evaluation, therefore a document based investigation will be complete. Documentation and ifu review: a review of the manufacturing records for the hmbl device of lot # c1449057 did not reveal any discrepancy related to the complaint issue. There is no evidence to suggest that this issue affects the entire lot # c1449057 ; upon review of complaints this failure mode has not occurred previously with this lot # c1449057. It may be noted that according to instructions for use, ifu0030- 7, the user is instructed to: ¿visually inspect with particular attention to joints, cracks and breaks. If any abnormality is detected that would prohibit proper working condition, do not use¿. As per step 5 of the instructions for use, ifu0030- 7, the user is instructed to ¿deploy band by slowly rotating spool downward until tension is released¿. There is nothing to suggest that the user did not follow the ifu. According to a reply email to cook medical about when the device would be returned the customer said the device would not be returned because it was user error. Root cause: additional information request on the 14th of november 2018 the doctor explains that the reason for the failure was because the practitioner was wearing gloves with lubricant on them making it easier to be harsh on turning the spool for deployment. The customer also confirmed that all the bands deployed at once. The correct operation of the medical device is required to run a safe and successful procedure. It is unlikely that the product left cirl with any defects so it is likely that this complaint occurred due to the user error. When using the hmbl product you are required to rotate the spool at a constant slow rate so the bands will deploy successfully, in this case the user rotated the spool too fast as the gloves they were wearing had lubricant on them causing the user to rotate the spool too fast. This caused all the bands to deploy at once. Summary: this complaint is confirmed based on customer testimony. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Bands did not want fire although suction was good. Additional information received 20-nov-18: "due to this problem occurring at this facility before therefore we realized that it's user error. At a cpd meeting a dr explained that because their gloves have lubricant on them therefore it's easy to be harsh on turning of wheel for deployment".
 
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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 
061334440
MDR Report Key8169017
MDR Text Key131795297
Report Number3001845648-2018-00591
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeZA
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
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2019
Device Model NumberG34063
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberC1449057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/17/2018
Event Location Hospital
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2018
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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