MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for OP-TELESCOPE, 30?, 4 MM CHANNEL WA33036A manufactured by Olympus Winter & Ibe Gmbh.
[41778873]
The suspect medical device was returned to the manufacturer for evaluation/investigation. The evaluation/investigation found the telescope in good working order with some signs of wear and tear. However, the inner surface of the telescope's working channel is damaged at its distal end. This damage is most likely caused by bending or torquing the lithotripsy probe against the telescope during the procedure, resulting in the release of metal particles. Therefore, this phenomenon was attributed to use error. The case will be closed from olympus side with no further actions. However, the reported phenomenon will be recorded for trending and surveillance purposes. In addition, the user will be informed about the investigation results and pro re nata retrained to correctly use the olympus medical devices.
Patient Sequence No: 1, Text Type: N, H10
[41778874]
Olympus was informed that during a percutaneous nephrolithotomy (pcnl) of the right kidney procedure, metal particles of an unknown origin appeared in the telescope's field of view inside the patient's kidney. Some of the foreign objects were reportedly flushed out with irrigation fluid, but it is unknown if any other particles remained inside the patient's kidney. No further information was provided, but the intended procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury. The patient was then hospitalized, in line with standard operating practice and not directly as a result of the reported phenomenon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2016-00017 |
| MDR Report Key | 5533842 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-02-18 |
| Device Manufacturer Date | 2006-02-24 |
| Date Added to Maude | 2016-03-30 |
| 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, 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 40 66966 |
| 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 | 0 |
| Brand Name | OP-TELESCOPE, 30?, 4 MM CHANNEL |
| Generic Name | OP TELESCOPES, AUTOCLAVABLE (WITH CHANNEL) |
| Product Code | FGA |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-24 |
| Model Number | WA33036A |
| Catalog Number | WA33036A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-03-30 |