MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-21 for ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29MM ECS29 manufactured by Ethicon Endo-surgery, Llc.
[1157392]
It was reported by the surgeon, "i did a laparoscopic sigmoid colectomy on friday. I used a laparoscopic gia to divide the bowel distally, using one reload. I then used an eea to perform the anastomosis. The stapler seemed to function appropriately, and i tested the anastomosis with air insufflation at the completion of the case. The anastomosis subsequently leaked, and at reexploration, the anterior staple line was disrupted. In the course of taking down the anastomosis at the second operation, some of the staples appeared to be incompletely closed. We saved some of them to show you. There were clearly consequences, as the patient is still critically ill in the icu with sepsis, even after repeat operation. "
Patient Sequence No: 1, Text Type: D, B5
[8144108]
Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-02976 |
| MDR Report Key | 1392391 |
| Report Source | 07 |
| Date Received | 2009-05-21 |
| Date of Report | 2009-04-28 |
| Date of Event | 2009-04-17 |
| Date Mfgr Received | 2009-04-27 |
| Date Added to Maude | 2009-05-28 |
| 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 CREKK RD |
| Manufacturer City | CINCINNATI OH 454242803 |
| Manufacturer Country | US |
| Manufacturer Postal | 454242803 |
| 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 - 29MM |
| Product Code | FHM |
| Date Received | 2009-05-21 |
| Model Number | NA |
| Catalog Number | ECS29 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-05-21 |