FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLUNT TIP TROCAR
MDR report key: 1081071
·
Received July 21, 2008
Report
- Report Number
- 3005075853-2008-00580
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 26, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/21/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE UNIVERSAL SEAL WAS NOT ASSEMBLED ON THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLUNT TIP TROCAR | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |