FDA Adverse Event
Malfunction
Summary report: N
VAPR HOOK ELECTRODE
MDR report key: 1509463
·
Received September 25, 2009
Report
- Report Number
- 1221934-2009-00363
- Event Type
- Malfunction
- Date Received
- September 25, 2009
- Date of Event
- September 9, 2009
- Report Date
- September 9, 2009
- Manufacturer
- DEPUY MITEK
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- 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
OUR REP REPORTS THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF A VAPR HOOK ELECTRODE BROKE OFF INTO THE PATIENT'S JOINT SPACE (LOT # 0905045). THE FRAGMENT WAS EASILY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPR HOOK ELECTRODE | ELECTROSURGICAL, CUTTING AND COAGULATING | GEI | DEPUY MITEK | 227305 | 0905045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |