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 2017-09-14 for SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES FG-0202 manufactured by Boston Scientific - Marlborough.
[86585857]
The exact age of the patient is unknown, however, it was reported the patient was over 18 years. Manufacturer: (b)(4). Device component code relates to problem code for the reported event of pressure sensor not detected. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[86585858]
This manufacturer report pertains to one of two devices used in the same procedure. Manufacturer report # 3005099803-2017-02791 pertains to the first symphion fluid management accessory and manufacturer report # 3005099803-2017-02792 to the second symphion management accessory. It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used during a polypectomy procedure performed on (b)(6) 2017. According to the complainant, during preparation, they received a faulty pressure sensor error message (captured in mfr report # 3005099803-2017-02791). A second fluid management accessory device was used but the same thing happened (captured in mfr report # 3005099803-2017-02792). The procedure was completed with a third symphion fluid management kit. There were no patient complications as a result of the 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 | 3005099803-2017-02791 |
| MDR Report Key | 6866256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2017-09-14 |
| 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 | 2017-09-14 |
| Model Number | FG-0202 |
| Lot Number | 0061770117 |
| Device Expiration Date | 2018-06-06 |
| 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 | 2017-09-14 |