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 2018-08-10 for SYMPHION FG-0612-R 74076 manufactured by Boston Scientific Corporation.
[116863370]
The investigation revealed that corrosion was found on the motor board near the hand piece motor circuit. It appeared saline had dripped into the unit where the top cover meets the front bezel and created an electrical short on the main board. The short activated the motor circuits and thus the resecting device triggered by itself. Given the event description and condition of the returned device, the cause was traced back to component failure. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.
Patient Sequence No: 1, Text Type: N, H10
[116863371]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a procedure performed on (b)(6) 2018. According to the complainant, during the procedure and outside the patient, the symphion resecting device started resecting immediately after connecting it into the symphion controller. The resecting device was inserted through the endoscope while the resecting device was activated in order to complete the procedure. There were no patient complications reported as a result of this 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 | 3005099803-2018-60021 |
| MDR Report Key | 7773671 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-10 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-08-28 |
| Device Manufacturer Date | 2014-10-30 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | NORTECH SYSTEMS |
| Manufacturer Street | 925 ENTERPRISE AVENUE , |
| Manufacturer City | MILACA MN 56353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56353 |
| 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-COAGULA |
| Product Code | PGT |
| Date Received | 2018-08-10 |
| Returned To Mfg | 2018-07-20 |
| Model Number | FG-0612-R |
| Catalog Number | 74076 |
| Lot Number | MC-0069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| 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 | 2018-08-10 |