MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for V-LOC 90 VLOCM1904 manufactured by Covidien Lp Llc North Haven.
[186581809]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186581810]
According to the reporter, during a robotic laparoscopic nephrectomy while performing anastomosis as the surgeon was pulling the suture, the needle broke off from the strand and fell into the cavity. The staff spent an extra hour searching for the missing needle. An x-ray was done to determine the positioning of the needle. Following x-ray, surgeon determined it was too risky to remove the needle due to the position. Surgeon ended case with a retained needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01380 |
| MDR Report Key | 9896442 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-LOC 90 |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
| Product Code | GAM |
| Date Received | 2020-03-30 |
| Model Number | VLOCM1904 |
| Catalog Number | VLOCM1904 |
| Lot Number | A8D0290VX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |