FDA Adverse Event
Malfunction
Summary report: N
FEA,DSCTR 5MM BLUNT NOSE
MDR report key: 416695
·
Received September 11, 2002
Report
- Report Number
- 1219602-2002-00159
- Event Type
- Malfunction
- Date Received
- September 11, 2002
- Date of Event
- June 4, 2002
- Report Date
- September 11, 2002
- Manufacturer
- SMITH & NEPHEW INC. ENDOSCOPY DIVISION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE BLUNT NOSE DISSECTOR BROKE DURING A GASTRECTOMY. WHEN THE INSTRUMENT WAS RETURNED, BOTH DUAL ACTION PIVOTS WERE MISSING. THE DESCRIPTION OF THE INCIDENT STATED THAT A BACKUP DEVICE WAS AVAILABLE AND THERE WAS NO DELAY TO THE CASE. IT WAS ALSO REPORTED THAT NO COMPLICATIONS OR PT INJURY RESULTED DUE TO THIS EVENT. HOWEVER, THIS INCIDENT IS REPORTABLE BECAUSE AT THE TIME OF THIS FILING IT CANNOT BE CONFIRMED THAT THE DUAL ACTION PINS DO NOT REMAIN IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEA,DSCTR 5MM BLUNT NOSE | DISSECTOR | GCJ | SMITH & NEPHEW INC. ENDOSCOPY DIVISION | NA | 430835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |