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 FG-0202 manufactured by Boston Scientific - Marlborough.
[82132883]
(b)(4). The device has been received for analysis; however the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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
[82132884]
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used in a hysteroscopy procedure performed on (b)(6) 2017. According to the complainant, during preparation, when they plugged the pressure sensor into the console, the controller prompted a faulty pressure sensor message. The procedure was completed with another fluid management accessory device. There were no patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02341 |
| MDR Report Key | 6776346 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-09 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-08-13 |
| Device Manufacturer Date | 2017-06-16 |
| 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 |
| 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 |
| Returned To Mfg | 2017-07-21 |
| Model Number | FG-0202 |
| Lot Number | 0060944208 |
| Device Expiration Date | 2018-05-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |