MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-09-30 for OLYMPUS BF-P160 NA manufactured by Olympus Optical Co. Ltd..
[725297]
Complaint description: the hospital reported 9 patient bronchial lavage samples showed "clusters" of cladosporium fungus contamination. Of the 9 patients, half of the patient had undergone procedures with the same endoscope. The hospital reported they found a hole in the instrument channel that they had previously missed during leak testing due to a faulty leak tester. The hospital reported that they could not directly link the endoscope to patient infection because the patients had already been infected before the procedures were performed. The patients were treated for the infections that had initially prompted their procedures, and all are reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
[7856881]
Investigation analysis: the scope was sterilized by eto and sent to olympus for technical investigation. The investigation revealed a build up of a yellowish/reddish stain on the k-mount unit wall at the body control unit. In addition, the instrument channel of the endoscope was found leaking with excessive tears marks at approximately 1cm from the distal end due to physical damage. As a result of the damaged channel, fluid invaded the scope and caused heavy corrosion in the body control unit. The up/down control knob was frozen due to the corrosion. Olympus cannot conclusively determine the cause of the user's experience. However, the physical condition of the scope cannot be ruled out as a contributing factor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2004-10103 |
| MDR Report Key | 918702 |
| Report Source | 07 |
| Date Received | 2004-09-30 |
| Date of Report | 2004-09-28 |
| Date Mfgr Received | 2004-09-28 |
| Date Added to Maude | 2007-09-27 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARK GAYLE |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355059 |
| Manufacturer G1 | OLYMPUS OPTICAL CO., LTD. |
| 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 | VIDEO BRONCHOSCOPE |
| Product Code | ENZ |
| Date Received | 2004-09-30 |
| Model Number | BF-P160 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 891660 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-30 |