MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-11-20 for OP-TELESCOPE, 10 MM, 6 DEGREE, 5.5 MM CHANNEL, OCULA A52001A manufactured by Olympus Winter & Ibe Gmbh.
[5299187]
Olympus was informed that a patient sustained an unspecified burn on the abdomen. No other information was provided but the suspect medical device was reportedly withdrawn from circulation after the event.
Patient Sequence No: 1, Text Type: D, B5
[12527416]
The suspect medical device was not yet returned to the manufacturer for evaluation/investigation. Therefore the exact cause of the patient's outcome 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. Olympus submits this incident as a medical device report (mdr) in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2014-00051 |
| MDR Report Key | 4283513 |
| Report Source | 05,06,07 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-06-26 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2014-12-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DANIEL WALDOW |
| Manufacturer Street | KUEHNSTRABE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | GM |
| Manufacturer Phone | 0669662955 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OP-TELESCOPE, 10 MM, 6 DEGREE, 5.5 MM CHANNEL, OCULA |
| Generic Name | OP TELESCOPES, AUTOCLAVABLE (WITH CH |
| Product Code | FEO |
| Date Received | 2014-11-20 |
| Catalog Number | A52001A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRABE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-20 |