MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[112553313]
The customer returned the clv-190 light source to olympus for evaluation. The user complaint was not confirmed. A visual inspection was performed on the returned device and no physical anomalies or irregularities were observed. The pump air pressure and activation were tested using a laboratory air pressure gauge. The air pump was toggled between on and standby, and functioned as intended. An air pump pressure check was performed and the device passed all olympus specifications. Based on the evaluation, the device passed the air pressure pump test. The low, medium and high modes measured within olympus specifications. Pump is working and fully functional. The exact cause of the reported event could not be determined. The clv-190 instruction manual warns users in section 5. 9? Air/water feeding.? ? Over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation.?
Patient Sequence No: 1, Text Type: N, H10
[112553314]
Olympus was informed that during three different post op evaluations, three patients experienced abdominal pain and gas due to over-inflation from the device. The user facility reported that the device had continuous air flow, while the air function was set to standby. The patients did not require any additional treatment or hospitalization. The patients were discharged home in stable condition. In addition, it was reported that during the procedure the user facility? S technician was able to confirm a continuous air flow from the lightsource after the ucr (insufflator) was powered off and the water bottle was disconnected from the side of the scope. This is 1 of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00361 |
| MDR Report Key | 7627944 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-21 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-06-06 |
| Model Number | CLV-190 |
| Catalog Number | CLV-190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-21 |