FDA Adverse Event
Other
Summary report: N
SLIMLINE 365 FIBER
MDR report key: 1202913
·
Received October 17, 2008
Report
- Report Number
- 2914019-2008-00056
- Event Type
- Other
- Date Received
- October 17, 2008
- Date of Event
- August 5, 2008
- Report Date
- October 13, 2008
- Manufacturer
- LUMENIS LTD.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
LUMENIS MADE REASONABLE ATTEMPTS TO RETURN THE SUBJECT FIBER FOR EVAL, HOWEVER, THE USER FACILITY DID NOT COMPLY. THEREFORE, THE PROBABLE ROOT CAUSE BASED ON THE REPORTED EVENT DESCRIPTION IS FIBER BREAKAGE, DUE TO BENDING IN CONTRADICTION TO PRODUCT LABELING. SHOULD ADDITIONAL INFO BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, PART OF THE FIBER BROKE INSIDE THE PATIENT'S KIDNEY. ATTEMPTS TO REMOVE THE FIBER WERE UNSUCCESSFUL. THE USER FACILITY REPORTED THE PATIENT DID NOT ENDURE ANY COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIMLINE 365 FIBER | FIBER | GEX | LUMENIS LTD. | 0642-370-01 | 0070220208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |