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 2018-06-20 for SYMPHION? TISSUE REMOVAL SYSTEM RESECTING DEVICE FG-0201 manufactured by Boston Scientific - Marlborough.
[111762745]
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
[111762746]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device used in a hysteroscopy procedure performed on (b)(6) 2018. According to the complainant, during procedure and inside the patient, the resecting device was used to do an endometrial sampling and noticed that there was a 400cc fluid loss early in the case. The physician advanced a little further with good visualization but at some point the deficit jumped to 800cc. Upon procedure closure, the physician suspected perforation and a leak into the abdomen. A laparoscopy was done and a hole was found in the uterus with a little bit of fluid in the cavity. The physician stitched it up and suctioned any fluid out from the patient. Reportedly, the physician was unsure if the perforation was caused by the symphion resecting device or the dilation at the beginning of the case. The procedure was completed using this device. There were no patient complications as a result of the event. The patient condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02003 |
| MDR Report Key | 7621710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-12-05 |
| Date Added to Maude | 2018-06-20 |
| 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 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| 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 | 2018-06-20 |
| Model Number | FG-0201 |
| Lot Number | 0065074600 |
| Device Expiration Date | 2018-12-05 |
| 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 | 2018-06-20 |