MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-10 for ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ECS29 manufactured by Ethicon Endo-surgery, Llc..
[1145645]
It was reported that four days post-op a lap sigmoid colectomy procedure, there was dehiscence on the right posterior side of the anastomosis. An open resection was performed to re-do the anastomosis. The pt received a temporary colostomy and currently remains in the hosp.
Patient Sequence No: 1, Text Type: D, B5
[8141005]
Info is unavailable; device was not returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-02213 |
| MDR Report Key | 1359736 |
| Report Source | 07 |
| Date Received | 2009-04-10 |
| Date of Report | 2009-03-18 |
| Date of Event | 2009-03-12 |
| Date Mfgr Received | 2009-03-17 |
| Date Added to Maude | 2009-04-16 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM |
| Product Code | FHM |
| Date Received | 2009-04-10 |
| Model Number | NA |
| Catalog Number | ECS29 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | GUAYNABO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-10 |