MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-08-02 for LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V WA97020A manufactured by Olympus Winter & Ibe Gmbh.
[81585868]
The suspect medical device was not returned to the manufacturer for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[81585869]
Olympus was informed that during an unspecified therapeutic endoscopic procedure, the light source malfunctioned. As a result, the operating field was not illuminated anymore and the endoscopic procedure had to be converted to open surgery. Furthermore, it was reported that another light source of the same model was not functioning either.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2017-00097 |
| MDR Report Key | 6759403 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-08-02 |
| Date of Report | 2017-11-28 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2017-02-20 |
| Date Added to Maude | 2017-08-02 |
| 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 | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | EN ELECTRONICNETWORK HAMBURG GMBH |
| Manufacturer Street | MEIENDORFER STRASSE 205 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V |
| Generic Name | DESKTOP LIGHT SOURCES |
| Product Code | NTN |
| Date Received | 2017-08-02 |
| Returned To Mfg | 2017-11-03 |
| Model Number | WA97020A |
| Catalog Number | WA97020A |
| ID Number | 04042761077613 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-02 |