MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2007-09-21 for OLYMPUS PCF-160AL manufactured by Olympus Medical Systems Corporation.
[20509506]
The user facility reported that during a diagnostic colonoscopy, pink and red lines appeared on the video screen resulting in image loss. The procedure was completed with a different, but similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[20811137]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of flickering with static and lines on the display. There were third party repairs noted on the light guide tube, electrical connector and burndy pin. There were severe dents and cracks observed on the distal tip plastic cover (c-cover), which caused the device to fail the insulation test. There was corrosion found inside the endoscope connector (s-connector), indicating fluid invasion, which appears to be due to user handling as the device passed leak testing. The device was tested with a temporary electrical connector and the video image was found to be appropriate. The image difficulty was isolated to third party repairs and fluid invasion. The device was serviced and returned to the customer. Additional comments: the pcf-160al advises users that the device should only be serviced by olympus technicians.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00139 |
| MDR Report Key | 916970 |
| Report Source | 00,05,06 |
| Date Received | 2007-09-21 |
| Date of Report | 2007-08-24 |
| Date Added to Maude | 2007-10-30 |
| 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 | 22-2 NISH-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 |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-09-21 |
| Model Number | PCF-160AL |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 903600 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-21 |