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 2015-04-17 for OLYMPUS TROCARS WA58365S manufactured by Olympus Winter & Ibe Gmbh.
[5737598]
Olympus was informed that during a video assisted thoracoscopic surgery (vats) on the left upper lobectomy procedure, the tip of the trocar spike became fractured and broke off inside the patient's chest cavity. The device fragment was retrieved using a sponge stick. However, the user facility was uncertain if all of the device fragments were retrieved from the patient. No x-ray was performed. There was no patient injury reported. Additionally, the procedure was successfully completed using a different but similar device. The patient was reported to be in good condition.
Patient Sequence No: 1, Text Type: D, B5
[13235776]
The device referenced in this report has not been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information or if the device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00173 |
| MDR Report Key | 4712020 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-04-17 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2015-06-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TROCARS |
| Generic Name | TROCARS SPIKE |
| Product Code | EWY |
| Date Received | 2015-04-17 |
| Model Number | WA58365S |
| Catalog Number | WA58365S |
| Lot Number | 087W-0014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2015-04-17 |