FDA Adverse Event
Malfunction
Summary report: N
VAPR GENERATOR
MDR report key: 1578874
·
Received December 31, 2009
Report
- Report Number
- 1221934-2009-00547
- Event Type
- Malfunction
- Date Received
- December 31, 2009
- Date of Event
- December 18, 2009
- Report Date
- December 18, 2009
- Manufacturer
- DEPUY MITEK
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE VAPR 3 UNIT WAS BEING USED WITH A SONY TRINITRON MODEL PVM-20M2MDU IN A KNEE ARTHROSCOPY. THEY STATE THAT THE VAPR 3 UNIT WOULD CREATE INTERFERENCE WITH THE VIDEO MONITOR WHEN ACTIVATED. THE DOCTOR COMPLETED THE CASE WITH THE SAME UNIT SETUP WITH NO CONSEQUENCE TO THE PATIENT. THE CUSTOMER TESTED THE VAPR 3 UNIT AGAINST ANOTHER VAPR 3 UNIT AND THE SECOND VAPR 3 UNIT WORKED FINE WITH THE ORIGINAL VIDEO MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPR GENERATOR | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION | GEI | DEPUY MITEK | 225021 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |