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 2019-01-03 for FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC330-C6337 60093 manufactured by Boston Scientific Corporation.
[131959596]
(b)(4). The device has been received for analysis. Upon 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
[131959597]
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 red/blue. The patient's anatomy was not visible on the center image when the video looked red/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 | 3005099803-2018-62389 |
| MDR Report Key | 8213575 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-03 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2015-12-16 |
| Date Added to Maude | 2019-01-03 |
| 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 | 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 | 2019-01-03 |
| Returned To Mfg | 2018-12-10 |
| Model Number | FSC330-C6337 |
| Catalog Number | 60093 |
| Lot Number | 0001000439 |
| 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 | 2019-01-03 |