FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2890601
·
Received November 21, 2012
Report
- Report Number
- 1717344-2012-01180
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- April 4, 2012
- Report Date
- November 16, 2012
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO PT INJURY. INITIAL INSPECTION OF THE DEVICE THAT WAS RETURNED DISCOVERED THAT TWO ACTIVATION DOTS WERE MISSING FROM INSIDE THE JAWS. THE DOTS WERE NOT RETURNED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 223941X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |