FDA Adverse Event
Other
Summary report: N
7817-CMCE SURGI-START KIT
MDR report key: 3834845
·
Received May 9, 2014
Report
- Report Number
- 9612030-2014-00029
- Event Type
- Other
- Date Received
- May 9, 2014
- Report Date
- May 8, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A X-RAY DETECTABLE SPONGE. THE CUSTOMER STATED THAT THE 4X4 XRD SPONGE CAME APART WHEN FEEDING THROUGH THE 12MM TROCAR DURING A ROBOTICS PROCEDURE. THE CUSTOMER FURTHER STATED THAT THERE WAS NO HARM TO THE PT AND NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS INCIDENT. THE CUSTOMER FURTHER STATED THAT THE ORIGINAL PROCEDURE WAS A ROBOTIC PROSTATECTOMY WITH LYMPHADENECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280987 | 7817-CMCE SURGI-START KIT | X-RAY DETECTABLE SPONGE | GDY | COVIDIEN | 573764 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |