• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 08/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The 1 x used hmbl-4-tri device involved in this complaint was returned to cook (b)(4) for evaluation. The device related to this occurrence underwent a laboratory evaluation on 09 nov 2018. There were no defects presents on the anoscope. When returned 1 band remained on the device the other bands were also present with the device. In the lab the bands were put back onto the device to check if the device was functioning. The bands deployed during the lab by gently turning the ratchet, band deployed and returned to a small size quickly, band slightly twisted when it shrank down to small size. Documentation and ifu review: prior to distribution, all hmbl-4-tri devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at cook (b)(4). A review of the manufacturing records for the hmbl device of lot # c1514068 did not reveal any discrepancy related to the complaint issue. There is no evidence to suggest that this issue affects the entire lot # c1514068 ; upon review of complaints this failure mode has not occurred previously with this lot # c1514068. 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. ¿ root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting. However it is possible that the user rotated the spool too quickly, resulting in all the bands deploying at once. When deploying the bands it requires the user to gently deploy the bands so they don't roll off the device all at once. It is also possible that the bands may have got caught on the inside of the anoscope causing them to fire prematurely. Summary: this complaint is confirmed based on customer testimony. According to the information reported, the patient did not experience any adverse effects due to this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
As reported to customer relations, "when using the device, they would go to deploy the bands but would lose suction and they would roll off into the barrel of the device. After unsuccessful deploying any band, they opened a new device to complete the procedure successfully. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8173016
MDR Text Key130625060
Report Number3001845648-2018-00601
Device Sequence Number1
Product Code FER
UDI-Device Identifier00827002340633
UDI-Public(01)00827002340633(17)190626(10)C1514068
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2019
Device Model NumberG34063
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberC1514068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/18/2018
Event Location Hospital
Date Manufacturer Received08/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-