MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-16 for EVIS EXERA III XENON LIGHT SOURCE CLV-190 manufactured by Olympus Medical Systems Corp..
[123867064]
The device was not returned to olympus for evaluation. The exact cause of the reported event could not be determined at this time. In addition, insufficient information regarding the reported device, patient and procedure was reported. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly. However, based on the reported information the operator? S technique cannot be ruled out as a contributory factor. The olympus sales representative reported that the most probable cause of the reported event could be attributed to both the ucr and clv-190 air supply being on at the same time. The instruction manual for the ucr warns,? During use, always stop the device like light source from supplying air. If stop is not selected, a mixture of air and co2 may be supplied into the patient body.? In addition, the instruction manual for the clv-190 (section 5. 9) also provides warning that states,? Over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation.?
Patient Sequence No: 1, Text Type: N, H10
[123867065]
Olympus was informed that during a pneumoperitineum procedure, the patient? S cecum was perforated. The patient was given versed and sentinol for sedation and the procedure lasted 30 minutes. The air from the light source (clv-190) and co2 from the regulation unit (ucr) were used simultaneously during the procedure as the physician switched back and forth between air and co2. The physician noted that both the air and co2 were on at the same time. A few hours after the procedure was completed, while the patient was in recovery, the patient experienced abdominal pain. It was determined that the patient needed a surgical procedure to treat a cecal perforation. 2 of 2 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00623 |
| MDR Report Key | 7970381 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2018-10-16 |
| 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 | 3 |
| Brand Name | EVIS EXERA III XENON LIGHT SOURCE |
| Generic Name | XENON LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2018-10-16 |
| Model Number | CLV-190 |
| Catalog Number | CLV-190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2018-10-16 |