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 2017-09-21 for SYMPHION? TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES FG-0202 manufactured by Boston Scientific - Marlborough.
[87159082]
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. Manufacturer: (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
[87159083]
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory was used during hysteroscopy myomectomy procedure performed on (b)(6) 2017. According to the complainant, three 3-liter saline bags were utilized during procedure; two saline bags were completely consumed and the third saline was partially consumed, which caused an over 2500 ml approximately fluid deficit loss inside the patient. The symphion system ifu ((b)(4)) states that the symphion system is designed for use with a single 2 liter or 3 liter irrigation usp saline bag. Use a single 2 liter or 3 liter irrigation ups saline bag only. Do not use multiple saline bags. Use of multiple saline bags increases the chance of fluid overload. The procedure was completed with this device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine. The patient was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02906 |
| MDR Report Key | 6882452 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-09-05 |
| Date Added to Maude | 2017-09-21 |
| 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 | 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 | 2017-09-21 |
| 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 | 1. Other | 2017-09-21 |