MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-27 for SMART STAPES PISTON .6 X 4.25 MM 70145927 manufactured by Osta.
[63339159]
The device has not been returned to olympus for evaluation. The exact cause of the reported event could not be determined at this time; however, the most probable cause could be attributed to the operator? S technique. The instruction manual for use states,? Care should be taken not to damage the bony structures, surrounding mucosa, chorda tympani, facial nerve, or any external tissue when applying heat to the wire loops. The smart thermal handle and tip produces a sufficient amount of heat to activate the smart piston within one second of activation. The shape-memory properties of the nitinol are designed to aid the surgeon in the crimping of the wire loops around the incus or malleus. In most cases, further crimping will not be necessary, however, the surgeon should always check the wire loops to determine if additional manual adjustment (tightening or loosening) of the crimp should be made. Following placement of the prosthesis, the ossicular chain is palpated, and the movement of the prosthesis is inspected.? As part of our investigation of this report, olympus made multiple follow ups by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.
Patient Sequence No: 1, Text Type: N, H10
[63339160]
Olympus was informed that the smart stapes piston implant will not autocrimp correctly and becoming loose overtime affecting the patient? S hearing. The physician performed a revision of a smart piston case from 2 years ago. The physician reported successful results after 18 months then about 6 months ago, the patient? S hearing returned to pre-operation level. It was additionally reported that the piston had detached off the incus. The piston was replaced with a conventional piston tef-platinum.
Patient Sequence No: 1, Text Type: D, B5
[67692123]
The device was returned to olympus for evaluation in a used condition. A visual inspection of the pinston under a microscope revealed biomaterial adhered on the device. In addition, the shaft was found bent. The cause of the reported event could not be conclusively determined at this time. The device was forwarded to the original equipment manufacturer (oem) for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[109798275]
This supplemental report is being submitted to provide the original equipment manufacturer (oem) investigation and to update. The implant device was forwarded to the oem. The oem was unable to confirm the reported device issue. The evaluation of the implant device showed indications of usage as it was returned in the opened position. To add, the wire, sleeve, and anchor were returned in tact with no evidence of separation. A device history review (dhr) was performed and found no abnormalities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00973 |
| MDR Report Key | 6206752 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-27 |
| Date of Report | 2017-07-13 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2016-12-27 |
| 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 | 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 | SMART STAPES PISTON .6 X 4.25 MM |
| Generic Name | SMART STAPES PISTON .6 X 4.25 MM |
| Product Code | ETB |
| Date Received | 2016-12-27 |
| Returned To Mfg | 2017-01-17 |
| Model Number | 70145927 |
| Catalog Number | 70145927 |
| Lot Number | MH616530 |
| 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 | 1. Other; 2. Required No Informationntervention | 2016-12-27 |