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 2017-11-07 for SYMPHION? TISSUE REMOVAL SYSTEM RESECTING DEVICE FG-0201 manufactured by Boston Scientific - Marlborough.
[91200886]
The exact age of the patient is unknown, however, it was reported the patient was over 18 years. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. (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
[91200887]
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion resecting device was used during hysteroscopic myomectomy procedure performed on (b)(6) 2017. According to the complainant, the procedure went great and ended with no patient complications. Two hours after the patient was discharged, she was admitted to the emergency room due to bleeding and was taken to the operating room because of vomiting and pain. The physician performed hysteroscopy, laparoscopic ultrasound and laparotomy. Per physician's finding, the uterus was intact and there was no perforation noted. The patient is currently stable in the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-03377 |
| MDR Report Key | 7005681 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-11-22 |
| Date Added to Maude | 2017-11-07 |
| 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 | 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 RESECTING DEVICE |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
| Product Code | PGT |
| Date Received | 2017-11-07 |
| Model Number | FG-0201 |
| Lot Number | 62985255 |
| Device Expiration Date | 2018-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2017-11-07 |