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 2019-11-19 for SYMPHION FG-0612-R 74076 manufactured by Boston Scientific Corporation.
[186020521]
(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
[186020522]
It was reported to boston scientific corporation on november 4, 2019 that a symphion controller was used in a dilation and curettage (d and c) procedure performed on (b)(6) 2019. According to the complainant, when they plugged in the resecting device into the controller the device started resecting and reciprocating on its own. The procedure was aborted due to this event. There were no patient safety issues reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-05664 |
| MDR Report Key | 9341891 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2019-11-19 |
| 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 SYSTEM INC |
| Manufacturer Street | NW 7791 1450 |
| Manufacturer City | MINNEAPOLIS MN 55485 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55485 |
| 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 | 2019-11-19 |
| Returned To Mfg | 2019-11-14 |
| Model Number | FG-0612-R |
| Catalog Number | 74076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-11-19 |