MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-29 for OLYMPUS EVIS DUODENOVIDEOSCOPE TJF-140F manufactured by Olympus Medical Systems Corporation.
[1355818]
The user facility reported that during a procedure, the user was unable to pass an unspecified instrument through the instrument channel of the endoscope due to a restriction. The users attempted to pass another instrument through the instrument channel several times but no result. The endoscope was withdrawn from the patient, and the procedure was completed using a different but similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8727261]
As part of our investigation with this matter, an olympus' endoscopy support specialist (ess) visited the user facility to obtain additional information regarding the reported event and to address the reported phenomenon. The ess was informed that the subject endoscope was loaner device. The ess determined that the facility performed a leak test and placed the loaner endoscope in the steris system 1 without performing a precleaning and manual cleaning. The ess was able to remove a yellow sponge like material from the instrument channel using a biopsy forceps (model unknown, which likely caused the restrictions noted by the users during the procedure. The ess further reported that nothing reportedly fell into the patient. The user facility claimed that they do not use these types of sponges. The channel was cleared and the device was reprocessed. The device was then returned to olympus for investigation. The evaluation confirmed that there was no restriction or blockage observed when the endoscope was tested using a biopsy forceps. The instrument and suction channel was examined using a boroscope and there was no problem found. The endoscope passed the air/water leak test. The exact cause of the user's report could not be conclusively determined; however, deviations from the recommended reprocessing procedures could not be ruled out as a contributory factor to the users experience. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00152 |
| MDR Report Key | 1781479 |
| Report Source | 06 |
| Date Received | 2010-07-29 |
| Date of Report | 2010-06-30 |
| Date of Event | 2010-06-29 |
| Date Mfgr Received | 2010-06-30 |
| Date Added to Maude | 2011-01-24 |
| 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 | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 4848965688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EVIS DUODENOVIDEOSCOPE |
| Generic Name | DUODENOVIDEOSCOPE |
| Product Code | FAK |
| Date Received | 2010-07-29 |
| Returned To Mfg | 2010-07-01 |
| Model Number | TJF-140F |
| Lot Number | UNK |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-29 |