MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-04-10 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[2605062]
Olympus was informed that during a therapeutic colonoscopy with polypectomy procedure, one of the users felt an electrical shock. The user was reportedly examined by a cardiologist and was said to be doing fine. There was no report of patient or user harm.
Patient Sequence No: 1, Text Type: D, B5
[9803096]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reported that the technician who experienced the electrical shock was holding the subject device at 30-40cm mark of the insertion tube while her hand was covered with fluid. The technician claimed to have initially felt a "twist" in her arm, followed by a jolt. Another nurse in the room reportedly observed the technician's hair sticking up at the time of the second occurrence. The technician, whom was reported to have a pacemaker, was examined by her cardiologist and was said to be fine. The intended procedure was said to have been completed and no patient injury was reported. The device referenced in this report was returned to olympus for evaluation. The distal end cover was noted to have indentations, nick, and cracks which caused it to fail the insulation test on the distal end side. This phenomenon was due to mishandling. However, the insertion tube passed the insulation test. Additionally, the referenced device passed the air and water test. The image was found foggy due to there was dried residue on the objective lens which was caused by insufficient cleaning. The device was refurbished. 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 | 8010047-2012-00117 |
| MDR Report Key | 2536233 |
| Report Source | 06,07 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-03-07 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-05-23 |
| 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 EVIS EXERA COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2012-04-10 |
| Returned To Mfg | 2012-03-14 |
| 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 | 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 | 2012-04-10 |