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 2019-03-12 for EEA TRIEEA28MT manufactured by Us Surgical Puerto Rico.
[138581461]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138581462]
According to the reporter, during a sigmoid colon resection procedure, the device stapler used and fired. However post-operatively, the patient came into the emergency room. They found out that the staple line was disrupted on the anterior side and about 1/3 of the anastomosis was opened on the staple line. They also found out that a large leak was present, but the tissue did not appear ischemic. To resolve the issue the surgeon had to give the patient a colostomy and will need to do a follow-up operation. Due to the problem the patient extends hospital stay for about 3-4 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2019-01322 |
| MDR Report Key | 8414031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-12 |
| 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 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EEA |
| Generic Name | PLATE, BASE, SHELLAC |
| Product Code | EEA |
| Date Received | 2019-03-12 |
| Model Number | TRIEEA28MT |
| Catalog Number | TRIEEA28MT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-12 |