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 2017-08-09 for SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES UNK891 manufactured by Boston Scientific - Marlborough.
[82127010]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[82127051]
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used during product testing performed on (b)(6) 2017. According to the complainant, when they plugged the fluid management kit, the controller prompted a faulty pressure sensor. There was no patient or procedure involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02411 |
| MDR Report Key | 6776408 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-09 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-08-09 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
| Product Code | PGT |
| Date Received | 2017-08-09 |
| Model Number | UNK891 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-09 |