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 2018-04-25 for SYMPHION? TISSUE REMOVAL SYSTEM RESECTING DEVICE FG-0201 manufactured by Boston Scientific - Marlborough.
[106584282]
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
[106584283]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device was used in a procedure performed on (b)(6) 2018. According to the complainant, during procedure and inside the patient, the resecting device was used to remove a fibroid in the uterus and the physician noticed that there was fluid deficit rising quickly. The procedure was stopped and a fluid deficit of 2000cc was noted. The physician suspected perforation but the patient's family refused to do additional laparoscopic procedure. The suspected perforation was not confirmed. Additionally, the fibroid was resected but half of the fibroid was free floating inside the patient. The floating fibroid was not retrieved and the patient is expected for evaluation a month after the procedure to check if the fibroid would naturally pass through or a second procedure is required. The patient's condition at the conclusion of the procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01339 |
| MDR Report Key | 7462351 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2018-04-25 |
| 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 | 2018-04-25 |
| Model Number | FG-0201 |
| Lot Number | 0064099478 |
| Device Expiration Date | 2018-11-13 |
| 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 | 2018-04-25 |