MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for RBI2 manufactured by .
[31333772]
This report is a retrospective report to include event on the database. Discussion with user and head of department at time of incident reveiled that the user had knowingly ignored the suction levels as per on the product ifu supplied with device. The user used 400% additional suction than manufacturer's instructions for use. Excessive suction caused a very large biopsy to be taken causing persistent bleeding from the biopsy site. A single stitch was used to closed the biopsy site which stopped the bleeding and the patient did not have any further effect from this incident. The ifu clearly states the amount of suction to use and warns against using excessive suction.
Patient Sequence No: 1, Text Type: N, H10
[31333773]
Oversized rectal biopsy specimen taken due to user error with incorrect suction level used. User stated that they purposely ignored the recommended suction level on the companies ifu supplied with the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005921952-2015-00001 |
| MDR Report Key | 5226889 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-12 |
| Date of Event | 2013-02-13 |
| Date Mfgr Received | 2013-02-13 |
| Date Added to Maude | 2015-11-16 |
| 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, SOUTH AUSTRALIA 5009 |
| Manufacturer Country | AS |
| Manufacturer Postal | 5009 |
| Manufacturer Phone | 8 83466400 |
| Manufacturer G1 | AUS SYSTEMS PTY LTD |
| Manufacturer Street | 3 CHARLES STREET |
| Manufacturer City | ALLENBY GARDENS, SOUTH AUSTRALIA 5009 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 5009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RBI2 |
| Generic Name | RBI2 SUCTION RECTAL BIOPSY SYSTEM |
| Product Code | FCK |
| Date Received | 2015-11-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-16 |