MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for COVIDIENT ENDO STITCH AUTO SUTURE SUTURING DEVICE REF 173016 manufactured by Covidien.
[178146411]
Patient in surgery for laparoscopic hysterectomy. Rn attempting to load covidien endo stitch auto suture suturing device and it would not load. Rn tried new suture and it was still unable to load. Equipment taken out of service. Equipment never reached the patient. No patient harm. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092803 |
| MDR Report Key | 9676965 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-30 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| 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 | COVIDIENT ENDO STITCH AUTO SUTURE SUTURING DEVICE |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATE DEVICE |
| Product Code | OCW |
| Date Received | 2020-02-05 |
| Catalog Number | REF 173016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | COVIDIENT ENDO STITCH AUTO SUTURE SUTURING DEVICE |
| Generic Name | ENDOSCOPIC TISSUE APPROXIMATE DEVICE |
| Product Code | OCW |
| Date Received | 2020-02-05 |
| Catalog Number | REF 173016 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |