FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2616243
·
Received June 7, 2012
Report
- Report Number
- 9610617-2012-00019
- Event Type
- Other
- Date Received
- June 7, 2012
- Date of Event
- May 1, 2012
- Report Date
- June 6, 2012
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A 2MM PORTION OF ELECTRODE TIP IS BROKEN OFF, POSSIBLY DUE TO STRESS OVERLOAD.
Description of Event or Problem · 1
ALLEGEDLY, DURING A SPINAL PROCEDURE, TIP OF PROBE BROKE AND 2MM PIECE REMAINS IN PATIENT. WE HAVE ADVISED DOCTOR TO REMOVE IT, BUT HAVE NO INFORMATION ON WHETHER THAT WILL BE DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | BIPOLAR PROBE INSERT | KNS | KARL STORZ GMBH & CO. KG | 28163FBE | YY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |