FDA Adverse Event
Malfunction
Summary report: N
4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE
MDR report key: 2090520
·
Received April 19, 2011
Report
- Report Number
- 2648666-2011-00109
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE DOCTOR THAT THE TIP OF THE PRODUCT CAME OFF. THE TIP WAS RECOVERED AND PULLED OUT OF THE BODY OF THE PT. IT WAS FURTHER REPORTED BY THE DOCTOR THAT THIS WAS THE SECOND TIME THIS HAS HAPPENED AND THAT HE WOULD NOT USE THE PRODUCT AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 999999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |