MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-05-10 for PROXIMATE ILS CIRCULAR STAPLERS CDH33 manufactured by Ethicon Endo Surgery, Inc..
[471636]
During a proctocolectomy with ileo-anal pouch procedure. The surgeon was performing an end to end ileo-anal pouch anastomosis as part of a protocolectomy. The purse string was tied around the anvil, and the gun successfully inserted transanally. The anvil was attached to the trocar, and the surgeon began to close the gun. Only one or two full turns of the gun where allowed however whent he anvil became detached from the trocar. Several attempts the gun was not able to close. Another gun was opened and used with the same anvil head, and closed and fired without problem is how the case was completed. No pt consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2006-02093 |
| MDR Report Key | 715495 |
| Report Source | 01,07 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-04-20 |
| Date of Event | 2006-04-13 |
| Date Mfgr Received | 2006-04-18 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-05-19 |
| 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 | GARY LEBLANC |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133378582 |
| Manufacturer G1 | ETHICON ENDO SURGERY, INC. (TORRES) |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 PARQUE |
| Manufacturer City | CUIDAD JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXIMATE ILS CIRCULAR STAPLERS |
| Generic Name | GDW |
| Product Code | DGW |
| Date Received | 2006-05-10 |
| Model Number | NA |
| Catalog Number | CDH33 |
| Lot Number | C4D600 |
| ID Number | NA |
| Device Expiration Date | 2001-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 704564 |
| Manufacturer | ETHICON ENDO SURGERY, INC. |
| Manufacturer Address | * CINCINNATI OH * US |
| Baseline Brand Name | PROXIMATE I L S CURVED INTRALUMINAL STAPLER |
| Baseline Generic Name | CIRCULAR STAPLERS |
| Baseline Model No | CDH33 |
| Baseline Catalog No | CDH33 |
| Baseline Device Family | PROXIMATE ILS CIRCULAR STAPLERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940967 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-10 |