FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DISPOSABLE SURGICAL TROCAR
MDR report key: 217752
·
Received April 6, 1999
Report
- Report Number
- 1527736-1999-01983
- Event Type
- Malfunction
- Date Received
- April 6, 1999
- Date of Event
- March 9, 1999
- Report Date
- March 12, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC. S.A DE C.V.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED DURING THE LAPAROSCOPIC NISSEN FUNDOPLICATION, THE REP REPORTED THE DOCTOR WAS USING NON BLADED OBTURATOR TROCARS IN THE CASE AND THE SEALS BROKE ON (6) TROCARS DURING THE PROCEDURE. THE DOCTOR THREW SOME OF THE TROCARS ON THE FLOOR AND STEPPED ON SOME OF THEM. THE CASE WAS COMPLETED AND THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DISPOSABLE SURGICAL TROCAR | TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. S.A DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | OYK |