MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-20 for OLYMPUS SCOPE CABLE EXERA II MAJ-1430 manufactured by Olympus Medical Systems Corporation.
[3099215]
Olympus was informed that the referenced device failed during a procedure. There was no further detail provided.
Patient Sequence No: 1, Text Type: D, B5
[10363222]
Olympus followed-up with the user facility to obtain add'l info regarding this report. The user facility reported that there was a complete loss of image during an unspecified colonoscopy procedure. The intended procedure was said to have been completed with a new cable. There was no pt harm reported. The device eval did not confirm the user's report. The referenced device was evaluated and the image was found flickering when the cable was manipulated at the round connector side. The reference device was evaluated with a (b)(4) cable tester and it passed the continuity check. There was an unstable connection internally with the wires. The referenced device had been forwarded to the original equipment mfr (oem) for further eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00434 |
| MDR Report Key | 2885311 |
| Report Source | 06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-23 |
| Date Mfgr Received | 2012-10-23 |
| Date Added to Maude | 2013-02-26 |
| 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 SCOPE CABLE EXERA II |
| Generic Name | SCOPE CABLE |
| Product Code | KQM |
| Date Received | 2012-11-20 |
| Returned To Mfg | 2012-10-23 |
| Model Number | MAJ-1430 |
| Catalog Number | MAJ-1430 |
| 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 | 2012-11-20 |