FDA Adverse Event
Malfunction
Summary report: N
FUSE ENDOSCOPY SYSTEM
MDR report key: 5060520
·
Received September 2, 2015
Report
- Report Number
- 3007591333-2015-00040
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Date of Event
- August 26, 2015
- Report Date
- September 1, 2015
- Manufacturer
- ENDOCHOICE INC.
- Product Code
- FDS
- PMA / PMN Number
- K141598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THE DEVICE AT THE MFR'S REPAIR SITE DID NOT REPORT ANY IMAGE ISSUES. THE SCOPE PASSED EVAL AND THE ISSUE COULD NOT BE REPLICATED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THERE WAS CENTER MONITOR IMAGE LOSS DURING A CASE. THERE WAS NO REPORT OF INJURY OR OTHER NEGATIVE HEALTH CONSEQUENCE TO ANY PT, AS THIS OCCURRED PRIOR TO THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583052 | FUSE ENDOSCOPY SYSTEM | COLONOSCOPE AND ACCESSORIES | FDS | ENDOCHOICE INC. | FUSE C38S MC90 | NOT APPLICABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |