FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM SPATULA TIP ELECTROSURGICAL PROBE (3BX)
MDR report key: 2070383
·
Received April 18, 2011
Report
- Report Number
- 2936485-2011-00238
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
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 A PROCEDURE, THE DOCTOR NOTICED THAT THE INSULATION ON THE UNIT HAD BEEN COMPROMISED WHEN CAUTERIZING. IT WAS FURTHER REPORTED THAT THE UNIT DID NOT CAUTERIZE IN THE EXACT LOCATION THAT THE DOCTOR HAD INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM, 33CM SPATULA TIP ELECTROSURGICAL PROBE (3BX) | ELECTROSURGICAL | GEI | STRYKER ENDOSCOPY SAN JOSE | 35647-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |