MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for ENDOSTITCH AUTOSUTURE 10MM 173016 manufactured by Medtronic.
[181220671]
The endo stitch autosuture device was being used for the lap nissen. This time the device refused to release the suture needle and as the surgeon was attempting to try again to remove the suture needle, the needle broke. Surgeon pulled out the device and a portion of the needle was still inside the device and the other part of the needle was left inside the pt. The surgeon proceeded then to do an egd to retrieve the other part of the needle. He was able to locate the needle inside and pulled out with an endoscopic grasper. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093249 |
| MDR Report Key | 9750613 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-11 |
| Date Added to Maude | 2020-02-25 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSTITCH AUTOSUTURE 10MM |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-02-24 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J9G0016EY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MA 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |