MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for OLYMPUS ENDOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[109008668]
As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. Additionally, no device was returned to olympus for evaluation. Since no model or serial number was provided, olympus was unable to perform a device service history review on the reported scope and provide additional information. If additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[109008669]
Olympus was informed that during an unspecified biopsy procedure, the surgeon pushed out an unknown substance from the scope. It is unknown if the substance fell into the patient; however, it was reported that the unknown substance was retrieved and was sent to an unspecified location to be tested. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00311 |
| MDR Report Key | 7528203 |
| Date Received | 2018-05-18 |
| Date of Report | 2018-05-18 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-18 |
| 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 | OLYMPUS ENDOSCOPE |
| Generic Name | UNKNOWN |
| Product Code | GCQ |
| Date Received | 2018-05-18 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-18 |