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 2016-05-24 for SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH SDTNB1000 manufactured by Superdimension Inc..
[45787599]
The device was not returned for evaluation. There were no anomalies identified during the internal review of the incoming inspection records for the triple needle brush, the biopsy needle, or the biopsy forceps. Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy. If additional information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[45787600]
The patient suffered a small left apical pneumothorax during a superdimension procedure. The pneumothorax was treated with a chest tube. If additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2016-00128 |
| MDR Report Key | 5675828 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-05-24 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 161 CHESHIRE LANE SUITE 100 |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2016-05-24 |
| Model Number | SDTNB1000 |
| Lot Number | RLT013599 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUPERDIMENSION INC. |
| Manufacturer Address | 161 CHESHIRE LANE SUITE 100 MINNEAPOLIS MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-05-24 |