MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-20 for OLYMPUS SIGMOFIBERSCOPE OSF-3 manufactured by Olympus Medical Systems Corp.
[19942046]
Olympus followed up with the user facility to obtain additional information regarding this report. The user facility staff reported that there was no apparent problem with the scope used during the procedure, but the physician had reportedly experienced minor difficulty with the air/water flow during the procedure. After replacing the air/water valve, no further issues were reported. The staff reported that they do not suspect the sigmoidoscope to be the cause of the patient's outcome. The procedure was reportedly completed utilizing the same device. The device referenced in this report was returned to olympus for evaluation. The evaluation indicated that the air/water flow and capacity on the device was within standard. The internal channel of the device was examined using a boroscope, and identified a yellowish and pinkish stain on the external portion of suction tube. There were white residues and debris inside the channel mount and suction cylinder unit of the device. As part of the investigation into this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess the facility's reprocessing practices and to provide in-service training if necessary. The exact cause of the patient's outcome could not be determined. This report is being submitted as an mdr is an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[19954276]
The user facility reported that the patient returned to the emergency room (er) a day after having undergone a therapeutic sigmoidoscopy. The patient reportedly experienced abdominal pain, minor rectal bleeding, fever with chills, and mucous in her bowel movements following the procedure. Blood tests were performed, and the patient was said to have been released from the facility on the same day. The attending physician reportedly called the patient the day following the er visit, subsequent to receiving the results of all blood tests. The results of all blood tests were said to be normal. However, the patient reported having the same symptoms, but with reduced diarrhea and scant bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2009-00233 |
| MDR Report Key | 1544403 |
| Report Source | 06 |
| Date Received | 2009-11-20 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-10-19 |
| Date Mfgr Received | 2009-10-21 |
| Date Added to Maude | 2011-03-15 |
| 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 SYSTEM CORP |
| 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 SIGMOFIBERSCOPE |
| Generic Name | SIGMOIDOSCOPE |
| Product Code | FAM |
| Date Received | 2009-11-20 |
| Returned To Mfg | 2009-10-22 |
| Model Number | OSF-3 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO 163-91 JA 163-91 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-20 |