FDA Adverse Event
Malfunction
Summary report: N
VAPR S90 ELECTRODE
MDR report key: 1191932
·
Received October 1, 2008
Report
- Report Number
- 1221934-2008-00471
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Report Date
- October 1, 2008
- 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 AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A ROOT CAUSE FAILURE ANALYSIS. THE INVESTIGATION'S CONCLUSIONS WILL BE THE SUBJECT MATTER IN THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE THE SURGEON OBSERVED THAT THE ELECTRODE WAS ARCING IN THE BODY, AND AT SOME POINT THERE WAS SOME "PATIENT TWITCHING". THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICE WAS DISCARDED BY THE USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPR S90 ELECTRODE | ELECTROSURGICAL, CUTTING & COAGULATING | GEI | DEPUY MITEK | 225370 | 0805092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |