FDA Adverse Event
Malfunction
Summary report: N
STRYKER ENDOSCOPY
MDR report key: 1037898
·
Received April 24, 2008
Report
- Report Number
- MW5006638
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING ARTHROSCOPIC SHOULDER SURGERY, SURGEON NOTED FLAME & SPARKS FROM STRYKER SERFAS ENERGY WAND, 90-S, LOT # 08070AE2. A SINGLE USE ITEM - REMOVED FROM STERILE FIELD. SERFAS ENERGY GENERATOR REMOVED AND INSPECTED. PT DID NOT EXPERIENCE HARM, NOR DID ANYONE PRESENT IN THE ROOM. STRYKER REP NOTIFIED. BIOMED DEPT HERE TO INSPECT UNIT. WILL SEND SERFAS UNIT OUT FOR EVALUATION (TO STRYKER), INCLUDING THE SINGLE USE ITEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER ENDOSCOPY | SERFAS ENERGY GENERATOR | GEI | STRYKER ENDOSCOPY | 279-000-000 | ||
| 2 | STRYKER ENDOSCOPY | SERFAS ENERGY GENERATOR (DISPOSABLE) | GEI | STRYKER ENDOSCOPY | 90-S | 08070AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |