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 2018-12-26 for FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC330-C6337 60093 manufactured by Boston Scientific Corporation.
[131476856]
(b)(4). A fuse 1c colonoscope was returned for analysis. A functional evaluation was performed and the reported image loss was confirmed due to a failed charged couple device (ccd). The ccd was replaced to resolve the issue. The observed damage to the returned device is consistent with component failure (expected or random). Therefore, a review and analysis of all available information indicated that the most probable root cause is cause traced 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
[131476857]
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a colonoscopy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, the video looked blue. The anatomy of the patient was not visible when the video turned blue. 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 | 3005099803-2018-62247 |
| MDR Report Key | 8196952 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2018-11-28 |
| Device Manufacturer Date | 2015-12-04 |
| Date Added to Maude | 2018-12-26 |
| 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 | 2018-12-26 |
| Returned To Mfg | 2018-12-13 |
| Model Number | FSC330-C6337 |
| Catalog Number | 60093 |
| Lot Number | 0001000393 |
| 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 | 2018-12-26 |