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 2015-08-12 for SHORTSHOT SAEED HEMORRHOIDAL LIGATOR WITH TRIVIEW ANOSCOPE HMBL-4-TRI manufactured by Cook Ireland.
[22802801]
This complaint report meets the reporting criteria of an fda mdr report based on part of the device falling off / breaking from the device most likely requiring medical intervention to remove a foreign body from the patient. Limited patient/event information was provided by the customer. If additional information is received at a later date a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[22802802]
The top of the device fell of during the procedure. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5
[27099522]
Based on additional information, this incident no longer meets the reporting criteria of an fda mdr report. Based on additional information, this incident no longer meets the reporting criteria of an fda mdr report.
Patient Sequence No: 1, Text Type: N, H10
[27099523]
This correction follow-up report is being submitted to cancel the initial report ref # 3001845648-2015-00154 that was submitted relating to this event. Reference the 'additional information' section for this justification.
Patient Sequence No: 1, Text Type: D, B5
[34319311]
Based on additional information, this incident no longer meets the reporting criteria of an fda mdr report. Initial complaint information received is as follows: the top of the device fell of during the procedure. The incident initially met reporting criteria of an fda mdr report based on part of the device falling off / breaking from the device most likely requiring medical intervention to remove a foreign body from the patient. Additional information was received on 31-aug-15. Based on the additional information it was confirmed that top of the device fell off during the procedure but it was still attached by the string and bands to the device. No intervention was required to removed any the part of the device from the patient. The consultant just pulled the whole device back out as the cap was still attached with the string. No adverse effects to the patient were reported as occurring. Based on the additional information, this incident no longer meets the reporting criteria of an fda mdr report. Complaints of this nature will continue to be monitored for emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[34319312]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2015-00154 |
| MDR Report Key | 4997860 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-12 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-07-16 |
| Date Facility Aware | 2015-07-16 |
| Date Mfgr Received | 2015-09-08 |
| Device Manufacturer Date | 2015-04-15 |
| Date Added to Maude | 2015-08-12 |
| 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 | MISS SINEAD QUAID |
| Manufacturer Street | O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Country | EI |
| Manufacturer Phone | 061334440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL LIGATOR WITH TRIVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FHN |
| Date Received | 2015-08-12 |
| Catalog Number | HMBL-4-TRI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 92 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND |
| Manufacturer Address | NATIONAL TECHNOLOGICAL PARK CASTLETROY LIMERICK |
| Brand Name | SHORTSHOT SAEED HEMORRHOIDAL LIGATOR WITH TRIVIEW ANOSCOPE |
| Generic Name | FER LIGATOR, HEMORRHOIDAL |
| Product Code | FER |
| Date Received | 2015-08-12 |
| Catalog Number | HMBL-4-TRI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 92 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND |
| Manufacturer Address | NATIONAL TECHNOLOGICAL PARK CASTLETROY LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |