FDA Adverse Event
Injury
Summary report: N
FUJINON COLONOSCOPE
MDR report key: 1229742
·
Received November 14, 2008
Report
- Report Number
- 2431293-2008-00009
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 6, 2008
- Report Date
- November 10, 2008
- Manufacturer
- FUJINON, INC.
- Product Code
- FDF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED UPON RECEIPT. THE DEVICE CONTAINED A BROKEN NOZZLE AND BROKEN DISTAL END CAP. THE DAMAGE IS CONSISTENT WITH IMPACT FROM BEING DROPPED OR HANDLED ROUGHLY.
Description of Event or Problem · 1
FUJINON REC'D A LETTER DATED 2008 INDICATING THAT FOLLOWING A ROUTINE COLONOSCOPY, THE PT EXPERIENCED PAIN AND DISCOMFORT. IT WAS DISCOVERED THAT THE PT'S COLON HAD BEEN PERFORATED. THE PERFORATION WAS REPAIRED AND THE PT IS FINE. THE CUSTOMER REPORTED THAT THERE "IS NO WAY TO KNOW FOR CERTAIN WHAT FACTORS CONTRIBUTED TO THIS PERFORATION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUJINON COLONOSCOPE | COLONOSCOPE | FDF | FUJINON, INC. | EC-450LS5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |