FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS SMALL ACCESS RETRACTOR
MDR report key: 1283744
·
Received January 12, 2009
Report
- Report Number
- 3005075853-2008-02070
- Event Type
- Malfunction
- Date Received
- January 12, 2009
- Date of Event
- September 8, 2008
- Report Date
- September 9, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K070198
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 10/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO A HAND ASSISTED CHOLECYSTECTOMY, THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE DEVICE WAS TORN. ANOTHER LIKE DEVICE WAS USED TO START AND COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS SMALL ACCESS RETRACTOR | NONE | GCJ | ETHICON ENDO-SURGERY, LLC | NA | E4KW5V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |