MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-15 for ENDO STITCH AUTO SUTURE 173016 manufactured by Covidien.
[4763193]
When using endostitch for 2nd suture, suture loaded fine but when put through sleeve the endostitch dropped suture into pelvic region. The suture was able to be removed intact using grasper. Another endostitch was required to be used with a different suture. Dates of use: (b)(6) 2014. Diagnosis or reason for use: laparoscopic hysterectomy. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038253 |
| MDR Report Key | 4109249 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-07 |
| Date Added to Maude | 2014-09-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STITCH AUTO SUTURE |
| Generic Name | SUTURE |
| Product Code | MFJ |
| Date Received | 2014-09-15 |
| Model Number | 173016 |
| Lot Number | J4E1075X |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD 02048 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-15 |