MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for ENDO STITCH 173016 manufactured by Covidien Lp.
[175851116]
10mm covidien endostitch suturing device was being used during surgical case. Atraumatic got stuck in instrument. Instrument was not attached to any part of patient when this happened. No harm to patient occurred. Surgeon removed instrument from patient and attempted to manually remove suture. At this time, the atraumatic broke. Portion of atraumatic still attached to instrument at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615684 |
| MDR Report Key | 9615684 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-06 |
| Report Date | 2020-01-07 |
| Date Reported to FDA | 2020-01-07 |
| Date Reported to Mfgr | 2020-01-22 |
| Date Added to Maude | 2020-01-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | ENDO STITCH |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATION DEVICE |
| Product Code | OCW |
| Date Received | 2020-01-22 |
| Model Number | 173016 |
| Catalog Number | 173016 |
| Lot Number | J9H18535Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |