MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-18 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[2311517]
Olympus was informed during a therapeutic colonoscopy with polypectomy the users advanced a clip in an attempt to stop bleeding; however, the user reportedly experienced resistance in the biopsy channel as the clip was being advanced. The user then noted that approx one inch of a plastic tube was observed having advanced from the distal end of the coloscope. The user withdrew the endoclip, and the coloscope was subsequently withdrawn from the pt. User facility personnel removed the plastic tube from the distal end of the scope by hand. The procedure was reportedly completed using the same colonoscope, but with a different endoclip. The pt was reportedly doing fine after the procedure. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9493017]
The user facility returned the subject colonoscope with a light blue transparent tube 5. 5 inches long with an outer diameter of 3. 17 mm. The inner diameter of the unk tube was 2. 52 mm and 3. 77 mm on the other, as one end was tapered. The tubing was kinked near the middle. The instrument channel and suction channel of the colonoscope were examined, and there were no abnormalities or restrictions noted. The eval also noted a leak in the electrical connector. The unit failed the insulation test due to a cracked distal end cover, cracked and discolored bending section cover glue. The objective lens was chipped and the image was found to be stained and off center. The light guide tube was buckled, angulation was reduced, and there was play on the control knobs. The eval of the endoscope found no components missing. The characteristics of the returned plastic tubing are not consistent with olympus endotherapy devices or accessories, nor components used in the service or mfg of the device. The device was serviced and was returned to the user facility. As part of our investigation into this report, an olympus endoscopy support specialist (ess) visited the user facility to assess their reprocessing practices. While present, the ess observed that the tube was appeared similar to another company's balloon dilator found at the user facility. 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 | 8010047-2011-00288 |
| MDR Report Key | 2351002 |
| Report Source | 06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-20 |
| Date of Event | 2011-10-17 |
| Date Mfgr Received | 2011-10-20 |
| Date Added to Maude | 2012-04-19 |
| 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 | 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 EVIS EXERA COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2011-11-18 |
| Model Number | CF-Q160AL |
| Catalog Number | CF-Q160AL |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2011-11-18 |