MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2016-10-24 for DORNHOFFER TI PORP 2MM 70141014 manufactured by Osta.
[58249624]
Olympus followed up with the user facility to obtain additional information regarding the reported event and was informed that the alleged contaminated implant was not used on the patient; the physician opened a new device and completed the procedure. There was no patient injury reported. The device was not returned to olympus for evaluation; however, a photographic image of the sterile blue tray was provided by the user facility. The image illustrated that the implant had been removed and a foreign material was inside the tray. Since the implant and its sterile packaging were not returned the foreign material cannot be confirmed as organic. As part of our investigation, a performance investigation was conducted by the oem. This investigation determined that the reported event was unlikely to have occurred during production. The personal protective equipment worn by packaging staff, along with cleaning and visual inspection procedures, would prevent contaminates from being packaged along with the product during the implant packaging process.
Patient Sequence No: 1, Text Type: N, H10
[58249685]
Olympus received a voluntary medwatch((b)(4)) which reports that during a middle ear implant procedure; the surgeon opened the sterile plastic tray lid and observed that a piece of bloody tissue was present along with the implant. The surgeon reported that there was no evidence of a break in sterile packaging.
Patient Sequence No: 1, Text Type: D, B5
[62419826]
The device and packaging was returned to olympus for evaluation. A visual inspection was performed and noted the blue container was unsealed with temporary tape holding the container in place. The device was removed from the blue container and there was no damage or foreign material noted on or inside of the dornhoffer interpositional device. Further inspection of the device packaging noted a foreign object inside the blue container in a separate location. Based on the investigation finding the root cause for the reported event could not be determined. The device and packing will be sent to the oem for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00813 |
| MDR Report Key | 6052859 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2016-10-24 |
| Date of Report | 2018-01-10 |
| Date of Event | 2016-08-22 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2007-08-28 |
| Date Added to Maude | 2016-10-24 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNHOFFER TI PORP 2MM |
| Generic Name | MIDDLE EAR IMPLANT |
| Product Code | ETB |
| Date Received | 2016-10-24 |
| Returned To Mfg | 2016-10-25 |
| Model Number | 70141014 |
| Catalog Number | 70141014 |
| Lot Number | 0732302453 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTA |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-24 |