FDA Adverse Event
Malfunction
Summary report: N
INDIGO BARE-TIP FIBEROPTIC
MDR report key: 241206
·
Received September 16, 1999
Report
- Report Number
- 1527736-1999-04909
- Event Type
- Malfunction
- Date Received
- September 16, 1999
- Date of Event
- August 6, 1999
- Report Date
- August 6, 1999
- Manufacturer
- INDIGO MEDICAL, INC.
- Product Code
- GEX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DR PERFORMED A BLADDER NECK INCISION WITH THE BARE TIP FIBER PRODUCT WITHOUT INCIDENT. THE DR BEGAN THE PROCEDURE WITH A POWER SETTING OF 10W. HE INCREASED THE POWER TO 15W TO ENHANCE TISSUE ABLATION. FINAL INCREASE IN POWER TO 20W WAS ACCOMPLISHED TO TEST LIMITS OF FIBER AND DETERMINE EFFECTS AT MAXIMUM POWER. TISSUE ABLATION COMPLETED WITHOUT INCIDENCE. REPORTED FOR CONTROL PURPOSES PER REQUEST FROM INDIGO QUALITY SYSTEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDIGO BARE-TIP FIBEROPTIC | INDIGO-FIBER | GEX | INDIGO MEDICAL, INC. | NA | M4ET1X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |