MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for SYMPHION FG-0202 manufactured by Boston Scientific Corporation.
[122510110]
The patient was undergoing an operative hysteroscopy with removal of submucous myoma. The myoma was easily removed, however there was bleeding from the attachment site. The symphion (ref (b)(4), lot # 67542685) was set up, ready to proceed but they could not get the tubing to prime. The patient began bleeding more heavily and the circulating nurse contacted the device rep who stated they were experiencing an equipment failure and instructed them to replace the device and try again. The surgeon instead chose to use an operative hysteroscope using glycine for distending medium and a wire loop. The surgery was subsequently completed. Per the surgeon, other than the equipment failure, there were no complications related to the procedure and patient was taken to recovery room in stable condition. Estimated blood loss: 350 cc. Manufacturer response for insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar, symphion (per site reporter). The rep instructed the operation room staff to send the device back to the company for reimbursement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7929511 |
| MDR Report Key | 7929511 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-13 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-02 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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-COAG |
| Product Code | PGT |
| Date Received | 2018-10-03 |
| Model Number | FG-0202 |
| Lot Number | 67542685 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| 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 | 2018-10-03 |