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 2018-08-21 for SYMPHION FG-0612 74076 manufactured by Boston Scientific Corporation.
[117706219]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a polypectomy procedure in the uterus performed on (b)(6) 2018. According to the complainant, during the procedure, upon connecting the resecting device into the symphion controller, the resecting device started resecting immediately without any prompt on the screen. The problem happened on three symphion resecting devices. The device was unplugged and it would not recognize the resecting device anymore that it was plugged in. The procedure was completed with another symphion controller. There were no patient serious injury or adverse effects to the patient as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-60074 |
| MDR Report Key | 7800703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-21 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-28 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2018-08-21 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | NORTECH SYSTEMS |
| Manufacturer Street | 925 ENTERPRISE AVENUE , |
| Manufacturer City | MILACA MN 56353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHION |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
| Product Code | PGT |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-08-23 |
| Model Number | FG-0612 |
| Catalog Number | 74076 |
| 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 CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-21 |