MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for EVIS EXERA III COLONOVIDEOSCOPE PCF-H190DL manufactured by Olympus Medical Systems Corp..
[185487785]
1 of 2 it was reported that during a routine colonoscopy procedure, the user noticed that the water irrigations appears to be causing a tear in the patient when the scope is in the cecum. The user was using the ofp-2 serial number ( b)(4) along with the scope. The user stopped the irrigation, checked the patient to make sure there is no additional bleeding. The procedure was completed using the same equipment with no patient harm or injury reported due to the event. The subject device has not yet been received for evaluation. If additional information is received this report will be supplemented. Related complaints: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00359 |
| MDR Report Key | 9802944 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-10 |
| Date Facility Aware | 2020-02-10 |
| Report Date | 2020-02-10 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA III COLONOVIDEOSCOPE |
| Generic Name | COLONOVIDEOSCOPE |
| Product Code | FDF |
| Date Received | 2020-03-06 |
| Model Number | PCF-H190DL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |