MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-12 for OLYMPUS OES-PRO TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.
[2895260]
Olympus was informed that the users experienced a complete loss of image during an unidentified procedure.
Patient Sequence No: 1, Text Type: D, B5
[10183170]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reportedly experienced a total loss of image during a cystoscopy procedure in which the intended procedure was completed with a different but similar device. There was no pt harm reported. The device referenced in this report was returned to olympus for evaluation. The evaluation found there was no image which was attributed to the outer tube and the reference pins were bucked excessively. The proximal end section was bent with indentation and tool marks. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00255 |
| MDR Report Key | 2752394 |
| Report Source | 06 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-31 |
| Date of Event | 2012-08-07 |
| Date Mfgr Received | 2012-08-31 |
| Date Added to Maude | 2012-12-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS OES-PRO TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2012-09-12 |
| Returned To Mfg | 2012-08-10 |
| Model Number | A22002A |
| Catalog Number | A22002A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-12 |