MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-04 for ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD EGIATRS45AMT manufactured by Covidien, Formerly Us Surgical A Divison.
[63870102]
(b)(4). (b)(6). No code available - reoperation no further details regarding patient, product or procedure were provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[63870103]
According to the reporter; after completion of a laparoscopic lower anterior resection procedure without any issues, in which two staplers were used for double-stapling-anastomosis, a major leakage / peritonitis was noted the next day and the patient had a reoperation. Surgical videos were reviewed the surgeon and account rep for the first operation and the reoperation. There was small hole, in which a 5 mm suction tube could be inserted, near the staple line (at almost the center of the ventral side) on the oral side intestine which had performed double-stapling-anastomosis. The mucous membrane turned outward. The site was sewed with 3 stitches during the reoperation. The patient is in good condition. During the first operation, the donut tissue of the anal side was confirmed removing from the anvil, however, surgeon checked the oral side only by eyes. The surgeon does not think this event occurred due to the products. The patient suffered larynx cancer, esophageal cancer and rectal cancer, however, the tissue was not fragile. There was no steroid administration. The event occurred/was noticed after the surgery. The procedure was completed with manual suturing. No bleeding occurred. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use. The devices were discarded at the hospital after the original procedure. The most recent report on the patient? S condition states they are doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-00014 |
| MDR Report Key | 6222954 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-12-05 |
| Date Added to Maude | 2017-01-04 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| 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 | ENDO GIA* TRI-STAPLE RR 45MM M/T RELOAD |
| Generic Name | MESH, SURGICAL, DEPLOYER |
| Product Code | ORQ |
| Date Received | 2017-01-04 |
| Model Number | EGIATRS45AMT |
| Catalog Number | EGIATRS45AMT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-04 |