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 2016-06-24 for SUPERTRAX BIOPSY FORCEPS SDBF1000 manufactured by Superdimension Inc..
[48108934]
The device was not returned for evaluation. The inspection record was reviewed and there were no anomalies observed associated to this issue. 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
[48108935]
A patient received an asymptomatic pneumothorax during a superdimension enb procedure biopsy, it was found on a post procedure x-ray. The patient was observed for 2 hours and then discharged. If additional information is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004962788-2016-00172 |
| MDR Report Key | 5747868 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-06-03 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2016-04-11 |
| Date Added to Maude | 2016-06-24 |
| 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 | SUPERTRAX BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2016-06-24 |
| Model Number | SDBF1000 |
| Lot Number | RLT015351 |
| 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 | 2016-06-24 |