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 2018-01-02 for SYMPHION? TISSUE REMOVAL SYSTEM RESECTING DEVICE UNK893 manufactured by Boston Scientific - Marlborough.
[96118253]
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. The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[96118254]
It was reported to boston scientific corporation on (b)(4) 2017 that a symphion resecting device was used in a procedure performed on unknown date. According to the complainant, the physician encountered uterine perforation during procedure. The cause of the perforation has not been confirmed. Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-03906 |
| MDR Report Key | 7156534 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-02 |
| Date of Report | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2018-01-02 |
| 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 | 2018-01-02 |
| Model Number | UNK893 |
| 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 | 2018-01-02 |