N
Patient 1
NO DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.
MAUDE MDR 5527455
- MDR report key
- 5527455
- Report number
- 2951238-2016-00331
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-02-10
- Date received
- 2016-03-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR DONNY SHAPIRO
- Address
- 2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
- Phone
- 408-408-4089
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-03-25 | 0 | 1. O |
Event Narratives#
D
Patient 1
OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC RIGHT REVISION STAPEDOTOMY PROCEDURE, THE PATIENT PRESENTED TO THE CLINIC DUE TO SIGNIFICANT DECREASE IN HEARING OVER A YEAR. AT THE BEGINNING OF THE SURGERY, A DE LA CRUZ PISTON WAS NOTED TO BE FRACTURED AT THE SHEPARD'S CROOK. THE FRACTURE DID NOT OCCUR DURING THE SURGERY. IT HAPPENED SOMETIME AFTER IT WAS IMPLANTED IN 2004. THE IMPLANT WAS REPORTED TO HAVE FRAGMENTED INSIDE OF THE PATIENT'S EAR. ALL THE PIECES WERE REMOVED DURING THE SUBSEQUENT SURGERY ON (B)(6) 2016. ACCORDING TO THE SURGEON, AFTER THE PROCEDURE AND UPON INSPECTION OF THE INCUS AND THE PISTON PROSTHESIS, IT WAS NOTED THAT THERE WAS SIGNIFICANT EROSION OF THE DISTAL ASPECT OF THE INCUS AND THERE WAS A FRACTURE OF THE PROSTHESIS ITSELF AT THE SHEPHERD'S CROOK. THE PROSTHESIS WAS EASILY REMOVED IN TWO PIECES BY LASERING THE MUCOSA AT THE LEVEL OF THE FOOTPLATE TO ASSIST IN REMOVAL. THERE WAS NO PATIENT INJURY REPORTED.
N
Patient 1
THIS SUPPLEMENTAL SUBMISSION CORRECTS THE REPORT TYPE AND REPORTABLE EVENT TYPE FROM A SERIOUS INJURY TO A MALFUNCTION AS THE FACILITY REPORTED THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE REPORT.
N
Patient 1
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULTS. THE BROKEN DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL AND MICROSCOPE INSPECTION REVEALED BIOMATERIAL ADHERED ON THE DEVICE, AND THERE IS DEFORMATION ON THE WHITE PLASTIC PART WITH STAINS. ADDITIONALLY, THE TWO BROKEN PIECES WERE MEASURED IN LENGTH WITH THE LONG PORTION AT 5.5MM, AND THE SMALL PORTION AT 1.5MM. (PER OLYMPUS REFERENCE GUIDE, THE PISTON FUNCTIONAL LENGTH STANDARD IS 4.25MM). THE SHAFT WAS ALSO FOUND TO BE BENT AND TWISTED. BASED ON THE INVESTIGATION FINDINGS, THE MOST LIKELY CAUSE OF THE DEVICE DAMAGE CAN BE ATTRIBUTED TO MANIPULATION, OR SIZING WITH EXCESSIVE STRESS ON THE HEAD AND SHAFT CAUSING THE DEVICE TO BREAK APART. THE INSTRUCTION MANUAL WARNS USERS: "AS ALL PROSTHESES ARE INHERENTLY DELICATE AND SOME MATERIALS, SUCH AS HYDROXYLAPATITE, ARE BRITTLE IN NATURE, CAREFUL HANDLING IS ESSENTIAL TO PREVENT DAMAGE DURING MANIPULATION, TRIMMING OR SIZING, AND IMPLANTATION. ALL TRIMMING OR SIZING SHOULD BE PERFORMED ON A CUTTING BLOCK WITH ONLY THE SHAFT RESTING ON THE SURFACE OF THE CUTTING BLOCK SO AS NOT TO PLACE EXCESSIVE STRESS ON THE HEAD AND SHAFT INTERFACE.?