MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-18 for SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE G34063 HMBL-4-TRI manufactured by Cook Ireland Ltd.
[130625060]
(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.
Patient Sequence No: 1, Text Type: N, H10
[130625061]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2018-00601 |
| MDR Report Key | 8173016 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-18 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-08-17 |
| Date Facility Aware | 2018-12-18 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2018-06-26 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FER |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2018-10-09 |
| Model Number | G34063 |
| Catalog Number | HMBL-4-TRI |
| Lot Number | C1514068 |
| Device Expiration Date | 2019-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 52 DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-18 |