MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for 020240 manufactured by Covidien Lp Llc North Haven.
[122626998]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[122626999]
According to the reporter, during a laparoscopic sigmoidectomy procedure, when the first device was used at the oral side of the colon, the needle was difficult to go through the tissue. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2018-05242 |
| MDR Report Key | 7912378 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-26 |
| 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 | 0 |
| Product Code | MFJ |
| Date Received | 2018-09-26 |
| Model Number | 020240 |
| Catalog Number | 020240 |
| Lot Number | 126-12 |
| 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 | 2018-09-26 |