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 2018-11-08 for FUSE FSC-3300-SL-R 60093 manufactured by Boston Scientific Corporation.
[126640529]
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. (b)(4). Although expected, 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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[126640530]
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a procedure performed on an unknown date. According to the complainant, during the procedure, it was noted that the exterior at the tip of the scope was torn. This caused fluids to leak into the scope, resulting in damage to the front camera. There were no patient complications reported as a results of this event. The procedure was completed with another scope. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61220 |
| MDR Report Key | 8053093 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-08 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2015-11-09 |
| Date Added to Maude | 2018-11-08 |
| 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 |
| Generic Name | ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT |
| Product Code | PEA |
| Date Received | 2018-11-08 |
| Returned To Mfg | 2018-12-07 |
| Model Number | FSC-3300-SL-R |
| Catalog Number | 60093 |
| Lot Number | 0001000378 |
| 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 | 2018-11-08 |