FDA Adverse Event
Injury
Summary report: N
2PC VSYS / PRT / LOCKS 4NDL LW PFL
MDR report key: 2274080
·
Received September 26, 2011
Report
- Report Number
- 1219930-2011-00802
- Event Type
- Injury
- Date Received
- September 26, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 18, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GCJ
- PMA / PMN Number
- K952748
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE DEVICE WAS LEAKING DURING OPERATION WHICH CAUSED THE PT BLEEDING AFTER IT WAS ASSEMBLED. THE PT WAS INVOLVED WITHOUT INJURY. THERE WAS NOT ANY BLEEDING AFTER THE OPERATION. MEDICAL INTERVENTION WAS REQUIRED. OPERATIVE TIME WAS EXTENDED BY 30 MINS OR MORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2PC VSYS / PRT / LOCKS 4NDL LW PFL | SURGICAL ACCESSORY | GCJ | UNITED STATES SURGICAL | NOE0603L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |