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 2017-06-29 for 020240 manufactured by Covidien Lp Llc North Haven.
[78708574]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78708575]
According to the reporter: occurred during a laparoscopic low anterior resection. The device was used for the purstring suture in the intestinal tract of the mouth side. The anvil was inserted into the cdh. The suture seemed a little loose but the surgeon determined that there was no problem. While firing the cdh, part of the purstring suture disengaged and the anastomosis was incomplete. The surgeon resected the unsuccessful anastomosis. He/she then snitched a ratchet of the device one step deeply and anastomosed again successfully. Additional tissue resection was necessary due to the product problem. Surgical time was extended by less than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2017-05905 |
| MDR Report Key | 6677363 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-06-29 |
| 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 LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MC DERMOTT 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 |
| Product Code | GDJ |
| Date Received | 2017-06-29 |
| Model Number | 020240 |
| Catalog Number | 020240 |
| Lot Number | 51-29 |
| 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 MC DERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-29 |