FDA Adverse Event
Malfunction
Summary report: N
REALIZE ENDOSCOPIC DISSECTOR
MDR report key: 1080037
·
Received July 17, 2008
Report
- Report Number
- 3005992282-2008-00106
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET UP FOR A GASTRIC PROCEDURE, THE PEEL POUCH OF THE DISSECTOR WAS NOT SEALED. HAD TO OPEN ANOTHER KIT TO USE ANOTHER DISSECTOR. NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ENDOSCOPIC DISSECTOR | LTI | OBTECH MEDICAL SARL | NA | ZKCBDF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |