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 2019-02-07 for SYMPHION FG-0201 74080 manufactured by Boston Scientific Corporation.
[135448374]
The complainant was unable to provide the device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the device has been 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
[135448375]
It was reported to boston scientific corporation on (b)(4) 2019 that a symphion resecting device was used during a hysteroscopy, dilatation and curettage, polypectomy procedure in the uterus performed on (b)(6) 2019. According to the complainant, during the procedure, the uterus was perforated while resecting. The procedure was completed with the device. There were no serious injury/adverse effect to patient as a result of the event. Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00487 |
| MDR Report Key | 8317941 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-02-07 |
| 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 | SMC COSTA RICA |
| Manufacturer Street | EDIFICIO B48 AVENIDA 0 |
| Manufacturer City | ZONA FRANCA COYOL, ALAJUELA |
| Manufacturer Country | CS |
| 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 | 2019-02-07 |
| Model Number | FG-0201 |
| Catalog Number | 74080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-02-07 |