MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for ENDOSCOPIC CO2 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[131319159]
As part of our investigation, an olympus sales representative contacted the customer to inquire about the inspection and pretest of the equipment prior to use and was informed that the?? Pre-procedure?? Verification of the air/water function was performed using sterile water to see if bubbles were coming out of the air water nozzle and verified the suction function of the device. However, the valves were not physically inspected for any default or residues. The device was not returned to olympus for evaluation. The exact cause of the reported event could not be determined at this time. The instruction manual for the ucr warns? During use, always stop the device and light source from supplying air. If stop is not selected, a mixture of air and co2 may be supplied into the patient body. Make sure that the adapter biopsy valve, the needle adjuster, the stopper, the connector section, and the connecting slider are not damaged.? In addition, the instruction manual for the clv-190 (section 5. 9) light source that is used with the ucr 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
[131319160]
Olympus was informed that during a colonoscopy, while introducing the endoscope towards the caecum, the surgeon visualized the presence of hematomas and stripes on the walls on the intestine, prompting the surgeon to immediately abort the procedure and withdraw the endoscope. The patient was sent to the radiology department for a ct scan which showed?? Free air?? In the patient's intestine. The patient was hospitalized for a few days for observation and was "treatment" with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00804 |
| MDR Report Key | 8192598 |
| Date Received | 2018-12-21 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-22 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2018-12-21 |
| 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 | ENDOSCOPIC CO2 REGULATION UNIT |
| Generic Name | CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2019-01-07 |
| Model Number | UCR |
| Catalog Number | UCR |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-12-21 |