MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-06 for TA PREMIUM 010460 manufactured by Covidien Lp Llc North Haven.
[126265830]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[126265831]
According to the reporter, during a laparoscopic right open hemicolectomy procedure, while transecting the right colon, the tip of the instrument did not seem to be aligning properly and the staple line didn't feel correct when firing or look correct post firing. The staple line was resected and re-stapled to resolve the issue. The surgeon had to free up more bowel to redo the anastomosis extending the procedure by 45 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2018-05876 |
| MDR Report Key | 8042391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-11-06 |
| 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 | TA PREMIUM |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2018-11-06 |
| Returned To Mfg | 2018-11-06 |
| Model Number | 010460 |
| Catalog Number | 010460 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-06 |