FDA Adverse Event
Malfunction
Summary report: N
VAPR S90 ELECTRODE
MDR report key: 1182710
·
Received September 25, 2008
Report
- Report Number
- 1221934-2008-00461
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- 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 ANALYSIS. UPON COMPLETION OF THE ANALYSIS, THE RESULTS WILL BE FORWARDED VIA THE FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP REPORTS THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE ELECTRODE'S BLACK INSULATING SHEATH AT THE DISTAL END PEELED OFF INTO THE PATIENT'S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED THE BODY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED BY USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPR S90 ELECTRODE | ELECTROSURGICAL, CUTTING & COAGULATING | GEI | DEPUY MITEK | 225370 | 0806070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |