MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-02-03 for OLYMPUS ENDOSCOPE REPROCESSOR OER-PRO UNK manufactured by Olympus Medical Systems Corporation.
[2525249]
Olympus was informed that the subject device emitted a burning odor and displayed an e11 error code. There was no adverse implant to pts or users.
Patient Sequence No: 1, Text Type: D, B5
[9634731]
Olympus followed up with the user facility to obtain add'l info regarding this report. The user facility reported that there was no arcing, sparking and open flame observed, only a burning odor. There was no adverse impacts to any pts or users reported. An olympus field service engineer (fse) visited the user facility and facility and evaluated the reprocessor. During the eval, thermal damage was noted to the cpu printed circuit board (pcb). The fse replaced the cpu, however the replacement cpu pcb also emitted a burning odor when a reprocessing cycle was initiated. The cpu board and pump unit were replaced, and the unit operated appropriately. The two cpu pcbs and the pump unit were returned to olympus for eval. The eval found components on both of the cpu boards with evidence of thermal damage. The resistance of the pump unit was measured at 0. 2 ohms which was significantly lower than the normal resistance reading indicating a short within the pump causing excessive current flow on the cpu pcb. The pump unit was inadvertently discarded, however the cpu pcbs have been forwarded to the original equipment mfr (oem) for further eval. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00027 |
| MDR Report Key | 2462876 |
| Report Source | 06,07 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-05 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| 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 | 0 |
| 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 HACHIOJI-SHI |
| Manufacturer City | 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 ENDOSCOPE REPROCESSOR |
| Generic Name | ENDOSCOPE REPROCESSOR |
| Product Code | FAM |
| Date Received | 2012-02-03 |
| Model Number | OER-PRO |
| Catalog Number | UNK |
| 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 TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-03 |