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 2018-06-13 for SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES FG-0202 manufactured by Boston Scientific - Marlborough.
[110863476]
The reported lot number does not provide a match in gcs2; therefore, the manufacture date and expiration date are unknown. (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
[110863477]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion fluid management accessory was used in a polypectomy procedure performed on (b)(6) 2018. According to the complainant during preparation, the tube connecting the aspiration pump and tissue catch was loose and burst open when the physician started to resect. The physician and or staff did not wear specific or goggles for eye protection when it happened. The procedure was completed with a different device. 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 | 3005099803-2018-01960 |
| MDR Report Key | 7595656 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-13 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-18 |
| Date Added to Maude | 2018-06-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-06-13 |
| Model Number | FG-0202 |
| 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 | 2018-06-13 |