MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-10-12 for OLYMPUS PCF-140L manufactured by Olympus Medical Systems Corporation.
[700386]
The user facility reported that a patient was tested positive for transient e. Coli bacteremia. The patient underwent a colonoscopy in 2007. Two days later, the patient called the facility complaining of abdominal pain and general malaise. The patient was advised to return to the facility for re-examination, but elected to visit the emergency room (er) of another facility instead. A ct scan and x-ray were performed, and no indication of colon perforation found. The er took duplicate blood samples, one of which was positive for e-coli and the other negative. The patient was started on regimen of antibiotics, and discharged the same day. On the following month, the original facility was notified that the patient was positive for e. Coli. The original facility immediately isolated the endoscope used on the patient. The instrument channel of the endoscope was flushed with sterile water and the flush sample was sent to a microbiology laboratory for testing. The sample test was said to be negative. The user facility examined all patient files that were examined with the subject device, and there were no additional reports of adverse events were identified. On the following day, blood samples were taken from the patient and tested. The results were negative. The patient was seen by an infectious disease physician on eight days later, and was diagnosed with transient e. Coli bacteremia.
Patient Sequence No: 1, Text Type: D, B5
[7880306]
The device referenced in this report was returned to olympus for investigation. The biopsy channel of the device was examined with the use of a boroscope and an infant telescope. The investigation found evidence of reddish discoloration on the biopsy channel wall at the bending section area at approximately 1 cm to 2 cm marks from the distal end. An accumulation of white debris inside the channel mount unit wall was also observed. In addition, a large scratch was noted in the middle of the objective lens, which caused a shadow on the image. This phenomenon was determined to be due to physical damage. Review of the device instrument history shows that the device has never been serviced by olympus since purchase. However, based on the information provided by the user facility, there was no direct evidence to suggest that the patient's e. Coli bacteremia resulted from the use of the device. The cause of the patient's outcome cannot be conclusively determined; however, insufficient cleaning cannot be ruled out as a contributing factor. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00147 |
| MDR Report Key | 926302 |
| Report Source | 00,05,06 |
| Date Received | 2007-10-12 |
| Date of Report | 2007-09-17 |
| Date of Event | 2007-08-27 |
| Date Added to Maude | 2007-10-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-12 |
| Model Number | PCF-140L |
| 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 | 900463 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-12 |