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 2017-12-21 for ENDOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..
[95530133]
No scope was returned to olympus for evaluation. Since no model and serial number were provided, olympus was unable to review the instrument service history. The cause of the reported event could not be conclusively determined. 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. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[95530134]
Olympus was informed that during an unspecified procedure, injury to the patient? S mucosa occurred due to difficulties with the retroflection of the scope. The scope was reportedly too rigid. The patient? S outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00780 |
| MDR Report Key | 7138303 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2017-12-04 |
| Date Added to Maude | 2017-12-21 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPE |
| Generic Name | UNKNOWN |
| Product Code | NWB |
| Date Received | 2017-12-21 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 1. Other | 2017-12-21 |