FDA Adverse Event
Injury
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 217654
·
Received April 6, 1999
Report
- Report Number
- 1527736-1999-01861
- Event Type
- Injury
- Date Received
- April 6, 1999
- Date of Event
- March 11, 1999
- Report Date
- March 11, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (6) DEVICES WERE USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED BY THE AFFILIATE THAT AFTER APPROXIMATELY THREE HOURS, ALL SEALS ON THE DISPOSABLE 512SD TROCARS TORE. THE CASE WAS EXTENDED 45 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DILATING TIP TROCAR | TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. S.A. DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |