FDA Adverse Event
Death
Summary report: N
ENDOPATH ULTRA VERESS NEEDLE
MDR report key: 205454
·
Received January 8, 1999
Report
- Report Number
- 1527736-1999-00126
- Event Type
- Death
- Date Received
- January 8, 1999
- Date of Event
- December 4, 1998
- Report Date
- December 10, 1998
- Manufacturer
- SYMBIOSIS CORP.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A LAPAROSCOPIC TUBAL LIGATION. IT WAS REPORTED IN THE COLUMBUS DISPATCH (NEWSPAPER) A PT'S DEATH OCCURRED DURING A LAPARASCOPIC TUBAL LIGATION. THE ETHICON, INC. SUTURE REP NOTIFIED THE "EES" REP OF THE ARTICLE. REP CONTACTED THE SURGERY CENTER AND ASKED IF EES PRODUCTS WERE INVOLVED. THE REP WAS ADVISED NO INFO COULD BE PROVIDED AND WOULD NOT ACKNOWLEDGE OR DENY IF EES PRODUCTS WERE INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ULTRA VERESS NEEDLE | INSUFFLATION NEEDLES | GCJ | SYMBIOSIS CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Death| O |