FDA Adverse Event
Malfunction
Summary report: N
CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
MDR report key: 3736487
·
Received January 31, 2014
Report
- Report Number
- 3006697299-2014-00007
- Event Type
- Malfunction
- Date Received
- January 31, 2014
- Report Date
- January 15, 2014
- Manufacturer
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Product Code
- LBK
- PMA / PMN Number
- K981262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS CRACKED AND IT DID NOT CONNECT TO THE CUSA. THERE WAS NO PATIENT CONTACT, NO PATIENT INJURY, NO REVISION/MEDICAL INTERVENTION REQUIRED; AND NO DELAY IN SURGERY. MULTIPLE REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT BUT TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68768 | CUSA EXCEL 23KHZ STRAIGHT HANDPIECE | ULTRASONIC SURGICAL PRODUCTS | LBK | INTEGRA LIFESCIENCES (IRELAND) LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |