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 2017-09-21 for SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES FG-0202 manufactured by Boston Scientific - Marlborough.
[88256650]
The exact age of the patient is unknown, however, it was reported the patient was over 18 years. Manufacturer: smc (b)(4). 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
[88256711]
Note: 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)(4) 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 | 3005099803-2017-02792 |
| MDR Report Key | 6882028 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2017-09-21 |
| 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 | 2017-09-21 |
| Model Number | FG-0202 |
| Lot Number | 0059242129 |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-09-21 |