MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-12 for FUSE FULL SPECTRUM ENDOSCOPY SYSTEM FSC-3300-SL 60093 manufactured by Boston Scientific Corporation.
[130050928]
(b)(4). 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
[130050929]
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, all images were lost. "the image reappears after a few instants. " the anatomy of the patient was not visible on the center image when the images were lost. The procedure was completed with another fuse 1c colonoscope. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61915 |
| MDR Report Key | 8154589 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2016-03-18 |
| Date Added to Maude | 2018-12-12 |
| 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 | 2018-12-12 |
| Model Number | FSC-3300-SL |
| Catalog Number | 60093 |
| Lot Number | 0000400438 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-12 |