MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-07-19 for RBI2 manufactured by .
[80380389]
This report relates to notice of incidents from a single user at a hospital in the (b)(6). The user failed to fully depress the trigger to activate the blade as per described in the product ifu supplied with the device. This device has been incident free with all other users at the hospital since its original purchase 11 years prior. Further technical training has been offered to the individual and other hospital staff and this is currently being conducted. The device required minor intervention for removal of the device from the submucosa tissue. The incidents did not cause any serious long term injury to the patients.
Patient Sequence No: 1, Text Type: N, H10
[80380390]
Submucosa tissue wedged between cutting blade due to user not following instructions for use to fully depress the device trigger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005921952-2017-00001 |
| MDR Report Key | 6724062 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-07-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PAUL ZADOW |
| Manufacturer Street | 3 CHARLES STREET |
| Manufacturer City | ALLENBY GARDENS, 5009 |
| Manufacturer Country | AS |
| Manufacturer Postal | 5009 |
| Manufacturer G1 | AUS SYSTEMS PTY LTD |
| Manufacturer Street | 3 CHARLES STREET |
| Manufacturer City | ALLENBY GARDENS, 5009 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 5009 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RBI2 |
| Generic Name | RBI2 SUCTION RECTAL BIOPSY SYSTEM |
| Product Code | FCK |
| Date Received | 2017-07-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-19 |