MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for ENDO STITCH AUTO SUTURING DEVICE #173016 manufactured by Covidien.
[78696912]
V-loc stitch came off suture during the procedure. This was immediately realized at the time of the event. A single view pelvic x-ray was taken to confirm the placement of the needle in the patient. A needle fragment was recovered and not the whole needle. (b)(4), sales rep with medtronic, in possession of the single use device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070672 |
| MDR Report Key | 6673111 |
| Date Received | 2017-06-26 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-08 |
| Date Added to Maude | 2017-06-28 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO STITCH AUTO SUTURING DEVICE |
| Generic Name | ENDO STITCH AUTO SUTURING DEVICE |
| Product Code | MFJ |
| Date Received | 2017-06-26 |
| Returned To Mfg | 2017-06-08 |
| Model Number | #173016 |
| Lot Number | J7B1516X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | VLOC 180 ABSORBABLE RELOAD |
| Generic Name | VLOC 180 ABSORBABLE RELOAD |
| Product Code | GAM |
| Date Received | 2017-06-26 |
| Returned To Mfg | 2017-06-08 |
| Model Number | VLOCA008L |
| Lot Number | N7C0412X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | VLOC 180 ABSORBABLE RELOAD |
| Generic Name | VLOC 180 ABSORBABLE RELOAD |
| Product Code | GAM |
| Date Received | 2017-06-26 |
| Returned To Mfg | 2017-06-08 |
| Model Number | VLOCA008L |
| Lot Number | N7C0412X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | VLOC 180 ABSORBABLE RELOAD |
| Generic Name | VLOC 180 ABSORBABLE RELOAD |
| Product Code | GAM |
| Date Received | 2017-06-26 |
| Returned To Mfg | 2017-06-08 |
| Model Number | VLOCA008L |
| Lot Number | N7C0412X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-26 |