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 2018-12-10 for FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC330-A6334 60093 manufactured by Boston Scientific Corporation.
[130049422]
(b)(4). A fuse 1c colonoscope was returned for analysis. A functional evaluation was performed and found a distorted center image. Additionally, corrosion and signs of past fluid invasion were found on the electrical connector. The reported issue was confirmed. The device was not properly cleaned after being used. Fluid was present in the electrical connector that caused the corrosion. This interfered with the imaging signals resulting in the intermittent imaging issue. Therefore, the most probable root cause is cause traced to maintenance.
Patient Sequence No: 1, Text Type: N, H10
[130049423]
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a colonoscopy performed on (b)(6) 2018. According to the complainant, during the procedure, the center image went in and out. The anatomy of the patient was not visible when the center image went in and out. Another fuse 1c colonoscope was used to complete the procedure. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61869 |
| MDR Report Key | 8147978 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2015-11-03 |
| Date Added to Maude | 2018-12-10 |
| 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 | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | ENDOCHOICE, INC. |
| Manufacturer Street | 11810 WILLS ROAD |
| Manufacturer City | ALPHARETTA GA 30009 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSE FULL SPECTRUM ENDOSCOPY SYSTEM |
| Generic Name | ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT |
| Product Code | PEA |
| Date Received | 2018-12-10 |
| Returned To Mfg | 2018-11-12 |
| Model Number | FSC330-A6334 |
| Catalog Number | 60093 |
| Lot Number | 0000700424 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-10 |