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 2018-10-30 for EEA 020250 manufactured by Covidien Lp Llc North Haven.
[125487065]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[125487066]
According to the reporter, while on colon during a laparoscopic low anterior resection, the size may have been too large and tore the tissue. When it was extracted from the patient, the staple line seemed intact. They tried to oversew but the tissue was bad. Eventually, they removed the anastomosis and redid with the same device which was smaller in diameter to complete the case. The surgical time was extended by more than 30 minutes due to the product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2018-05746 |
| MDR Report Key | 8019546 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-10-30 |
| 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 | EEA |
| Generic Name | SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) |
| Product Code | KOA |
| Date Received | 2018-10-30 |
| Model Number | 020250 |
| Catalog Number | 020250 |
| 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 | 2018-10-30 |