FDA Adverse Event
Other
Summary report: N
9610617-2007-00010
MDR report key: 978644
·
Received May 11, 2007
Report
- Report Number
- 9610617-2007-00010
- Event Type
- Other
- Date Received
- May 11, 2007
- Product Code
- HKK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
WE DID NOT RECEIVE ANY OF THE CAMERA EQUIPMENT OR THE SCOPE USED IN THIS PROCEDURE BACK FOR EVAL. HOWEVER, WE DID ADDRESS VARIOUS REPROCESSING ISSUES (CLEANING CHEMICALS, FLASH STERILIZATION, ANTIFOG SOLUTION, MIXING STERILIZATION MODALITIES, ETC.) AT THIS ACCOUNT IN LATE 2006 THAT HAD A NEGATIVE IMPACT ON THEIR SCOPE VISUALS. IT IS POSSIBLE THAT THE SCOPE THEY WERE USING WAS SIMILARLY AFFECTED. AFTER THIS INCIDENT WAS REPORTED, OUR SALES REP BROUGHT IN HIS SAMPLE SCOPES AND PROCEDURES WERE COMPLETED WITH NO GRAINY PICTURE COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HKK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |