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 2017-12-05 for ENDOSCOPIC CO2 REGULATION UNIT UCR manufactured by Olympus Medical Systems Corp..
[93819894]
The referenced co2 regulation unit was not returned to olympus for evaluation. The cause of the reported event could not be determined at this time. However, user handling could not be ruled out as a contributory factor to the reported event. The instruction manual warns users when the endoscopic co2 regulation unit is used in combination with the upper/lower gastrointestinal endoscope that, 1) over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism and/or perforation. 2) anytime you observe an irregularity in the endoscopic co2 regulation unit, immediately stop using the endoscopic regulation unit and withdraw the endoscope from the patient slowly as described in the endoscope? S instruction manual.
Patient Sequence No: 1, Text Type: N, H10
[93819895]
Olympus was informed that the patient? S cecum was perforated during a colonoscopy procedure. The patient had two polyps removed using an olympus colonoscope (cf-hq190l), co2 regulation unit (ucr) and a non-olympus hot snare. However, following the procedure the patient complained of abdominal pain. No additional procedures were performed for the perforation; however, the patient did experience a longer stay for iv antibiotics, pain medication and imaging studies that revealed free air in the abdomen. The patient had a follow-up visit with the doctor on (b)(6) 2017 and the patient is doing well. The user facility reported it was a difficult procedure due to restricted mobility inside the patient? S colon and they are unsure which device caused or contributed to the perforation. 1of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00754 |
| MDR Report Key | 7083483 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-05 |
| Date of Report | 2018-04-26 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2017-12-05 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC CO2 REGULATION UNIT |
| Generic Name | ENDOSCOPIC CO2 REGULATION UNIT |
| Product Code | FCX |
| Date Received | 2017-12-05 |
| Model Number | UCR |
| Catalog Number | UCR |
| Lot Number | N/A |
| ID Number | 04953170239113 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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. Other | 2017-12-05 |