FDA Adverse Event
Malfunction
Summary report: N
5MM X 32CM STRYKERPROBE L-TIP
MDR report key: 2003797
·
Received February 7, 2011
Report
- Report Number
- 2936485-2011-00080
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 25, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE UNIT CAME OFF AND FELL INTO THE PATIENT. IT WAS FURTHER REPORTED THAT THE TIP WAS REMOVED WITHOUT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM X 32CM STRYKERPROBE L-TIP | SUCTION/IRRIGATION | GCX | STRYKER ENDOSCOPY SAN JOSE | 10A0689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |