FDA Adverse Event
Malfunction
Summary report: N
CAPIO SUTURE BL MF 0 TC-43/HR 26"
MDR report key: 2211933
·
Received August 10, 2011
Report
- Report Number
- 3004365956-2011-00316
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 2, 2011
- Manufacturer
- TELEFLEX
- Product Code
- GAO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WILL BE RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
EVENT WAS REPORTED AS: THE SURGEON THREW THE CAPIO SUTURE DEVICE AND WHEN HE PULLED OUT THE SUTURE THE BULLET TIP WAS NOT ATTACHED. THE BULLET TIP WAS LODGED IN THE SACROSPINOUS LIGAMENT. THE DECISION WAS MADE TO LEAVE THE TIP LODGED IN THE LIGAMENT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIO SUTURE BL MF 0 TC-43/HR 26" | CAPIO SUTURE | GAO | TELEFLEX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |