MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-04-15 for ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ECS29 manufactured by Ethicon Endo-surgery, Llc.
[15010590]
It was reported that during lap sigmoid procedure, the donuts were good, but during the leak test, it was visually noted that there were lots of bubbles. Leakage was confirmed. The physician had to perform a temporary ileostomy on the patient. Surgery was prolonged forty five mins. There were no adverse consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[15457563]
Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-02336 |
| MDR Report Key | 1363105 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-04-15 |
| Date of Report | 2009-03-26 |
| Date of Event | 2009-03-25 |
| Date Mfgr Received | 2009-03-25 |
| Date Added to Maude | 2009-04-21 |
| 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 | 2009-04-15 |
| Model Number | NA |
| Catalog Number | ECS29 |
| Lot Number | E4MJ50 |
| 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 | 2009-04-15 |