FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 2132757
·
Received June 17, 2011
Report
- Report Number
- 1056128-2011-00051
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 23, 2011
- Report Date
- May 23, 2011
- Manufacturer
- STRYKER SUSTAINABILITY SOLUTIONS
- Product Code
- NLQ
- PMA / PMN Number
- K10053
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A VISUAL EXAMINATION OF THE RETURNED ULTRASONIC SCALPEL REVEALED A SMALL (0.5MM X 0.7MM) PIECE OF DEBRIS INSIDE THE PACKAGING. INFRARED SPECTROSCOPY ANALYSIS IDENTIFIED THE PIECE AS SILICONE BASED. THE MOST PROBABLE SOURCE OF THE DEBRIS WAS DETERMINED TO BE FROM A MACHINE USED DURING THE REPROCESSING PROCESS.THIS IS THE FIRST COMPLAINT STRYKER SUSTAINABILITY SOLUTIONS HAS RECEIVED FOR THIS TYPE OF ISSUE SO NO TREND ANALYSIS IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN PULLING AN ULTRASONIC SCALPEL FROM INVENTORY THERE WAS A SMALL "SPECK" ON THE HANDLE OF THE DEVICE. THE DEVICE WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | N/A | NLQ | NLQ | STRYKER SUSTAINABILITY SOLUTIONS | FCS9 | 1358342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |