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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 Difficult or Delayed Positioning (1157); Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device involved in this complaint was not returned for evaluation, a document based review was complete with the available information. Document review including ifu review: prior to distribution hmbl-4-tri devices are subjected to a visual inspection, and functional checks to ensure device integrity. These inspections, and functional checks are outlined in internal procedures in place at cirl. A review of the manufacturing records for hmbl-4-tri of lot number c1610929 did or did not reveal any discrepancies that could have contributed to this complaint issue. The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number (pr268455 from the same customer). C1610929 was inspected with no non-conformances. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1610929. The short shot saeed hemorrhoidal multiband ligator with triview anoscope is used to ligate haemorrhoids facilitated by an anoscope. As per the instructions for use, ifu0030-7, users are advised of the following: "if the package is opened or damaged when received, do not use. Visually inspect with particular attention to joints, cracks or breaks. If an abnormality is detected that would prohibit proper working condition, do not use. ¿ the ifu states that, "the device may be used with an alternative anoscope if preferred. If an alternative endoscope is used, please consult relevant packaging, label and instructions for use. "however, as a precaution, it is recommended that the "inner lumen diameter of the anoscope must be compatible with shortshot maneuvers within lumen of alternative anoscope with adequate clearance to avoid dislodging bands". In addition, "banding should begin at the most proximal location from the anal sphincter and proceed distally because passing shortshot over a previously placed band may dislodge the band. " root cause review: a definitive root cause could not be determined from the available information. A possible root cause could be attributed to user technique; if suction was not released or too much tissue was sucked into the tip of the device, this may have caused the bands to slip off the haemorrhoid as the tissue may not have bulged around the band holding the bands in place, or if the user did not begin at the most proximal location from the anal sphincter and proceed distally resulting in passing the shortshot over a previously placed band this may dislodge the band. Another possible cause for this complaint may be that the device was damaged during transportation or storage. However, as the conditions of transport or storage are unknown, it is not possible to conclusively determine this as a root cause of the complaint. Summary: the complaint is confirmed based on the customer's 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, "customer reported hemorrhoid bander issues to [dm]. Customer and dm believe, based on usage, that it is a suction issue with the "cap"; when they go to deploy a band the band slips off the hemorrhoid. Procedures were all completed with additional devices from the same gpn. ".
 
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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 Key8873571
MDR Text Key215134339
Report Number3001845648-2019-00402
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeCA
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 07/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2020
Device Model NumberG34063
Device Catalogue NumberHMBL-4-TRI
Device Lot NumberC1610929
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/12/2019
Event Location Hospital
Date Manufacturer Received07/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2019
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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