MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-30 for FUJINON EC-450LP5 COLONOSCOPE manufactured by Fujinon Corp..
[713572]
During a colonoscopy procedure, the image went black. There were no reported injuries to the patient. It was not confirmed that the malfunction occurred during a procedure until 2007.
Patient Sequence No: 1, Text Type: D, B5
[7865892]
The returned colonoscope was evaluated. The problem with no image was confirmed. The cha harness wire was loose. The exact of the loose wire could not be confirmed. No injury to patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431293-2007-00008 |
| MDR Report Key | 935656 |
| Report Source | 05 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-09-25 |
| Date Mfgr Received | 2007-10-12 |
| Date Added to Maude | 2007-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10 HIGH POINT DR. |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9736335600 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJINON EC-450LP5 COLONOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-30 |
| Returned To Mfg | 2007-09-25 |
| Model Number | EC-450LP5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 935448 |
| Manufacturer | FUJINON CORP. |
| Manufacturer Address | 1-324 UETAKE KITA-KU SAITAMA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-30 |