D
Patient 1
THE USER FACILITY RETURNED THE SUBJECT DEVICE AND THE ASSOCIATED DEVICES TO OLYMPUS FOR INSPECTION DUE TO AN UNSPECIFIED PT INCIDENT.
MAUDE MDR 3019494
- MDR report key
- 3019494
- Report number
- 9610773-2013-00026
- Event key
- 0
- Event type
- 3
- Date received
- 2013-03-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- 2400 RINGWOOD AVE SAN JOSE CA 95131 US
- Phone
- 484-484-4848
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS OES 4000 TELESCOPE | TELESCOPE | OLYMPUS WINTER & IBE GMBH | FBP | A1931A | A1931A | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-03-11 | 0 | 1. D |
Event Narratives#
N
Patient 1
OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT A PT EXPIRED DURING AN UNSPECIFIED PROCEDURE WHERE OLYMPUS EQUIPMENT WAS USED. NO FURTHER INFORMATION WAS PROVIDED. THE SUBJECT DEVICE AND ASSOCIATED DEVICES WERE RETURNED TO OLYMPUS FOR EVAL. THE EVAL ON THE SUBJECT DEVICE NOTED A SHADOW AND BLUR ON THE IMAGE DUE TO A CRACKED OPTICAL SYSTEM LENS, AND DEBRIS UNDERNEATH THE OPTICAL SYSTEM LENS. IN ADDITION, THE OUTER TUBE WAS SLIGHTLY BENT, WHICH IS ATTRIBUTED TO PHYSICAL DAMAGE. THE RETURNED DEVICES WERE TESTED AS A SYSTEM AND NO MALFUNCTIONS WERE NOTED. THE DEVICES WERE RETURNED TO THE USER FACILITY UNREPAIRED PER THE USER FACILITY'S REQUEST. THE EXACT CAUSE OF THE PT OUTCOME REMAINS UNK. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.