FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS THUNDERBEAT 5MM, 20CM, INLINE GRIP
MDR report key: 3810178
·
Received February 4, 2014
Report
- Report Number
- 8010047-2014-00071
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- January 2, 2014
- Report Date
- January 6, 2014
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THIS WILL BE SUPPLEMENTED IF DEVICE EVAL BECOMES AVAILABLE.
Description of Event or Problem · 1
DURING NON ANATOMICAL LIVER RESECTION, THE PTFE PAD OF THE SUBJECT DEVICE BECAME WORN AND STARTED TO PEEL OFF AT THE TIP. THERE WAS NO FRAGMENT OF THE PAD IN PATIENT. A SHORT CIRCUIT ERROR MESSAGE KEPT APPEARING SO THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73577 | OLYMPUS THUNDERBEAT 5MM, 20CM, INLINE GRIP | THUNDERBEAT HANDPIECE | GEI | OLYMPUS MEDICAL SYSTEMS CORPORATION | TB-0520IC | 29K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |