MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE G34063 HMBL-4-TRI manufactured by Cook Ireland Ltd.
[131795297]
(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.
Patient Sequence No: 1, Text Type: N, H10
[131795298]
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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2018-00591 |
| MDR Report Key | 8169017 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-06-14 |
| Date Facility Aware | 2018-12-17 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2018-02-02 |
| Date Added to Maude | 2018-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FER |
| Date Received | 2018-12-17 |
| Model Number | G34063 |
| Catalog Number | HMBL-4-TRI |
| Lot Number | C1449057 |
| Device Expiration Date | 2019-02-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 132 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-17 |