FDA Adverse Event
Malfunction
Summary report: N
7383 GOMCO DELUXE 1.3
MDR report key: 1553885
·
Received November 18, 2009
Report
- Report Number
- 1282497-2009-00042
- Event Type
- Malfunction
- Date Received
- November 18, 2009
- Date of Event
- January 1, 2009
- Report Date
- November 13, 2009
- Manufacturer
- COVIDIEN
- Product Code
- FHG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2009, THAT A CUSTOMER HAD A PROBLEM WITH A GOMCO. THE CUSTOMER REPORTS THAT WHEN TIGHTENING THE CLAMP IT WOULD NOT THREAD ALL THE WAY DOWN PROVIDING A TIGHT SEAL, CREATING EXCESS BLEEDING. AS A RESULT, SURGICEL WAS APPLIED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7383 GOMCO DELUXE 1.3 | GOMCO | FHG | COVIDIEN | 52000033 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |