MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-06 for EVIS EXERA XENON LIGHT SOURCE CLV-160 manufactured by Olympus Medical System Corporation.
[39753335]
Olympus contacted the user facility to obtain further information regarding the events. The hospital reported that the physician complained the air-flow coming from the light source seemed too high. An olympus sales representative visited the user facility and was unable to duplicate the user's experience. The light source was returned to olympus for investigation. The light source was evaluated and the customer's report could not be duplicated, the device performed normally. The warning in olympus instruction manual states the operator must assess the condition of the patient and use clinical judgment to set the flow rate from the pump to a suitable level to avoid patient trauma. The flow control should always be set to min at the start of the procedure and be increased progressively to a level commensurate with the clinical condition of the patient. The most likely cause of the reported event is due to the user setting the flow rate too high at the start of the procedure.
Patient Sequence No: 1, Text Type: N, H10
[39753336]
Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015. Based upon this review, we are submitting this mdr to separately account for each of the three patients involved in this event. The user facility reported three patients became distended during their procedures. In one case, a rectal tube was placed in order to relieve the distension. No medical intervention was needed for the other two cases. All procedures were completed with the same device. No patient injury was reported. Please cross reference mfr. Report numbers: 8010047-2005-00046 and 2951238-2016-00142 to account for the three patients as referenced in the original report. The following report will be supplemented to cross reference the two associated complaints: 8010047-2005-00046
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00141 |
| MDR Report Key | 5482813 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-06 |
| Date of Report | 2016-03-04 |
| Date Mfgr Received | 2005-04-20 |
| Date Added to Maude | 2016-03-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355161 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE, ENDOSCOPE, XENON ARC |
| Product Code | GCT |
| Date Received | 2016-03-06 |
| Returned To Mfg | 2005-04-20 |
| Model Number | CLV-160 |
| Catalog Number | CLV-160 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO, 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-06 |