FDA Adverse Event
Malfunction
Summary report: N
TORRENT IRRIGATION TUBING
MDR report key: 3010908
·
Received March 14, 2013
Report
- Report Number
- 1528319-2013-00010
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 15, 2013
- Manufacturer
- UNITED STATES ENDOSCOPY GROUP, INC.
- Product Code
- GCJ
- Removal / Correction Number
- 1528319-03-07-2013-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REMEDIAL ACTION IS REQUIRED DUE TO THE RISK OF INJURY FROM SLIPPING OR FALLING FROM EXCESS WATER ON THE FLOOR. BASED ON THE INFO PROVIDED, THERE WAS NO INJURY TO EITHER PT OR USER.
Description of Event or Problem · 1
THE DEVICE IS CONNECTED TO SPECIFIED TUBING AND ACCESSORIES AND IS USED TO PROVIDE IRRIGATION DURING ENDOSCOPIC PROCEDURES. IT WAS REPORTED THAT DURING A PROCEDURE A SIGNIFICANT AMOUNT OF FLUID LEAKED FROM THE JUNCTION POINT BETWEEN THE WHITE CONNECTOR AND THE TUBING. THERE WAS NO REPORTED HARM TO PT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108196 | TORRENT IRRIGATION TUBING | IRRIGATION TUBING | GCJ | UNITED STATES ENDOSCOPY GROUP, INC. | 711560 | 82943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |