FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 358328
·
Received September 13, 2001
Report
- Report Number
- 1527736-2001-04892
- Event Type
- Malfunction
- Date Received
- September 13, 2001
- Date of Event
- July 31, 2001
- Report Date
- August 16, 2001
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A USER FACILITY MEDWATCH WAS RECEIVED IN 08/2001. THE MEDWATCH STATED THAT A "PIECE OF THE SOFT RUBBER VALVE BROKE OFF AND DROPPED INTO THE ABDOMEN. THE PIECE WAS NOT RETREIVED, WOULD NOT BE VISIBLE ON X-RAY." THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41982 | ENDOPATH DILATING TIP TROCAR | TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. | NA | P4LY94 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |