MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-18 for OLYMPUS SIGMOIDOFIBERSCOPE OSF-3 manufactured by Olympus Medical System Corporation.
[16044591]
User facility personnel reported that several patients had reportedly complained of an allergic reaction following sigmoidoscopy over a period of several months. Olympus was informed that sigmoidoscopes at the user facility were not being reprocessed in accordance with the instructions for use, and the user facility was significantly deviating from the recommended cleaning instructions including not performing pre-cleaning, leak testing, nor completely submerging the endoscope into reprocessing chemicals. The user facility was also reportedly insufficiently brushing and flushing the sigmoidoscopes channels, and was exposing the devices to reprocessing chemicals for varying lengths of time.
Patient Sequence No: 1, Text Type: D, B5
[16117864]
Olympus contacted the user facility via telephone and in writing to obtain add'l info regarding this report, but only limited info was provided. The user facility reported that a total of five patients complained of allergic reactions post sigmoidoscopy. Four out of the five patients reportedly developed hives, and one patient complained of shortness of breath. The fifth patient was immediately taken to emergency room of a nearby hospital, but was not admitted. The physician at the emergency room could not determine the cause of the patients reaction. All five patients referenced in this report. There was no further info provided by the user facility. The device referenced in this report was not returned to olympus for eval. An olympus endoscopy support specialist (ess) visited the user facility to obtain more info, and to assess the reprocessing practices at the user facility. The ess reported that conflicting info was provided to him by different staff members at the user facility. However, the ess determine that based on the info provided, that user facility personnel were not reprocessing their sigmoidoscopes in accordance with the recommended reprocessing protocol. The ess provided inservice training regarding appropriate reprocessing of endoscopes and provided educational materials. The user facility is reportedly purchasing add'l equipment and reprocessing supplies including an automated endoscope reprocessor (aer). This report is being submitted as an mdr in an abundance of caution. See mfr # 8010047-2010-00162 for a related report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00161 |
| MDR Report Key | 1812571 |
| Report Source | 05,06 |
| Date Received | 2010-08-18 |
| Date of Report | 2010-07-20 |
| Date Mfgr Received | 2010-07-20 |
| Date Added to Maude | 2011-03-17 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS SIGMOIDOFIBERSCOPE |
| Generic Name | SIGMOIDOFIBERSCOPE |
| Product Code | FAM |
| Date Received | 2010-08-18 |
| Model Number | OSF-3 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-18 |