FDA Adverse Event
Other
Summary report: N
SENSATION MICROSCIS S/S BAY STR 90/217MM
MDR report key: 734705
·
Received July 1, 2006
Report
- Report Number
- 2916714-2006-00049
- Event Type
- Other
- Date Received
- July 1, 2006
- Report Date
- June 27, 2006
- Manufacturer
- AESCULAP, INC.
- Product Code
- LRW
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT THE ITEM AND ALL AVAILABLE INFO WILL BE FORWARDED FOR ANALYSIS TO THE MFR, AESCULAP.
Description of Event or Problem · 1
DURING CRANIOTOMY, SURGEON USING MICROSCISSOR TO CUT TISSUE AND INSTRUMENT FELL APART IN THE SURGEON'S HANDS. PROLONGED SURGERY TEN MINUTES TO LOCATE ANOTHER INSTRUMENT. THE SCREW IS MISSING AND CAN NOT ACCOUNT FOR IT. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFO. NO FURTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSATION MICROSCIS S/S BAY STR 90/217MM | INSTRUMENT MICROSURGICAL EXCLUDING OPTICAL DEVICES | LRW | AESCULAP, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |