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 2018-03-16 for SYMPHION? TISSUE REMOVAL SYSTEM RESECTING DEVICE FG-0201 manufactured by Boston Scientific - Marlborough.
[102585731]
The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date 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
[102585732]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device was used during a polypectomy procedure performed on (b)(6) 2018. According to the complainant, during procedure and inside the patient, the physician had difficulty dilating and accessing the cervix because it was small and very deep in the pelvis. The physician eventually was able to gain access into the cervix but the visualization of the scope was poor. The resection of the polyp was proceeded for about 20 minutes with very limited visualization. It was noted that the outflow on the tubing turned red with blood. The physician felt she has done enough and the procedure was stopped due to the bleeding. Reportedly, there was either a perforation or false passage. The patient was sent to the main operating room because the physician was not able control the bleeding. The patient condition at the conclusion of the procedure was reported to be poor. Post operatively, the patient was confined in the intensive care unit for a period of time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00829 |
| MDR Report Key | 7344598 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-03-16 |
| 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 | 2018-03-16 |
| Model Number | FG-0201 |
| 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. Required No Informationntervention | 2018-03-16 |