FDA Adverse Event
Injury
Summary report: N
3.5MM LAT SERFAS ENERGY PROBE
MDR report key: 2221530
·
Received August 17, 2011
Report
- Report Number
- 2648666-2011-00202
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 5, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, THE CERAMIC PORTION OF THE TIP OF THE UNIT FELL OFF INTO THE PT. THE BROKEN PIECE COULD NOT BE RETRIEVED. IT WAS FURTHER REPORTED THAT THE DOCTOR DID NOT BEND THE UNIT DURING USE AT FIRST; HOWEVER, IT WAS BENT LATER DURING THE CASE. THIS IS WHEN THE UNIT BROKE AND THE PART FELL OFF. IT WAS FURTHER REPORTED THAT A SECOND SURGERY WOULD BE REQUIRED IN ORDER TO REMOVE THE BROKEN PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM LAT SERFAS ENERGY PROBE | PROBE | GEI | STRYKER ENDOSCOPY PUERTO RICO | 11153AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |