MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-11 for ENDOPATH STEALTH CIR STAPLER ECS25 manufactured by Ethicon Endo-surgery, Llc.
[922292]
It was reported that during a lap roux-en-y procedure, the blue tip had a crack. Another device was used to complete the procedure. There was no adverse consequence to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8103990]
Info anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2008-01072 |
| MDR Report Key | 1112644 |
| Report Source | 05,06 |
| Date Received | 2008-08-11 |
| Date of Report | 2008-07-23 |
| Date of Event | 2008-07-22 |
| Date Mfgr Received | 2008-07-23 |
| Date Added to Maude | 2009-04-03 |
| 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 STEALTH CIR STAPLER |
| Product Code | FHM |
| Date Received | 2008-08-11 |
| Model Number | NA |
| Catalog Number | ECS25 |
| Lot Number | C4DF7F |
| ID Number | BATCH#=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 | 2008-08-11 |